Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT02384434
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011855', 'term': 'Radiodermatitis'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stadtermanbm@upmc.edu', 'phone': '4126475554', 'title': 'Barbara Stadterman, MPH, CCRP', 'organization': 'UPMC Hillman Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years and 5.5 months for the study population.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 12, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Grade 3 or Higher Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.3', 'spread': '32.0', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '25.6', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.6', 'spread': '27.2', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '30.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.4', 'spread': '34.7', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '22.3', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '24.5', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '30.7', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '15.5', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '29.0', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.5', 'spread': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '20.5', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'Overall QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.1', 'spread': '17.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'categories': [{'measurements': [{'value': '54.4', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '44.1', 'spread': '29.7', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'categories': [{'measurements': [{'value': '35', 'spread': '19.7', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'categories': [{'measurements': [{'value': '44.4', 'spread': '34.6', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '44.7', 'spread': '28.3', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '49.4', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'categories': [{'measurements': [{'value': '49.4', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'categories': [{'measurements': [{'value': '51.8', 'spread': '25.7', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'categories': [{'measurements': [{'value': '20.3', 'spread': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'categories': [{'measurements': [{'value': '27.3', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'categories': [{'measurements': [{'value': '41.6', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'categories': [{'measurements': [{'value': '79.8', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'categories': [{'measurements': [{'value': '55.3', 'spread': '18.1', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'categories': [{'measurements': [{'value': '51.4', 'spread': '19.3', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - Overall QOL', 'categories': [{'measurements': [{'value': '50.7', 'spread': '21.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '17.7', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.1', 'spread': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.1', 'spread': '31.3', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.7', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.4', 'spread': '26.5', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '19.7', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.6', 'spread': '28.5', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '29.5', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '33.4', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.9', 'spread': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.4', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - Overall QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '13.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4.5-7.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.4', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.9', 'spread': '24.8', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '18.7', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.4', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '23.6', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'spread': '31.3', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '27', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '15.9', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.3', 'spread': '28.1', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - Overall QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.0', 'spread': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7.5-10.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'categories': [{'measurements': [{'value': '37.5', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '17.5', 'spread': '35.0', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'categories': [{'measurements': [{'value': '12.5', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'categories': [{'measurements': [{'value': '12.5', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '18.8', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '28.1', 'spread': '32.9', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'categories': [{'measurements': [{'value': '43.8', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'categories': [{'measurements': [{'value': '25.0', 'spread': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'categories': [{'measurements': [{'value': '30', 'spread': '35.6', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'categories': [{'measurements': [{'value': '3.8', 'spread': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'categories': [{'measurements': [{'value': '15', 'spread': '17.3', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'categories': [{'measurements': [{'value': '27.5', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'categories': [{'measurements': [{'value': '42.5', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'categories': [{'measurements': [{'value': '21.9', 'spread': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - Overall QOL', 'categories': [{'measurements': [{'value': '30', 'spread': '11.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10.5-13.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'categories': [{'measurements': [{'value': '46.9', 'spread': '29.5', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '12.5', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'categories': [{'measurements': [{'value': '6.2', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'categories': [{'measurements': [{'value': '12.5', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '18.8', 'spread': '23.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'categories': [{'measurements': [{'value': '43.8', 'spread': '31.5', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'categories': [{'measurements': [{'value': '7.5', 'spread': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'categories': [{'measurements': [{'value': '17.5', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'categories': [{'measurements': [{'value': '7.5', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'categories': [{'measurements': [{'value': '25.0', 'spread': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'categories': [{'measurements': [{'value': '22.5', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'categories': [{'measurements': [{'value': '45', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'categories': [{'measurements': [{'value': '50', 'spread': '20.4', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - Overall QOL', 'categories': [{'measurements': [{'value': '35', 'spread': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13.5-16.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'categories': [{'measurements': [{'value': '35.4', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '21', 'spread': '31.5', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'categories': [{'measurements': [{'value': '11.6', 'spread': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'Chewing', 'categories': [{'measurements': [{'value': '16.7', 'spread': '23.6', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '25.6', 'spread': '29.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '17.6', 'spread': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'Recreation', 'categories': [{'measurements': [{'value': '40.8', 'spread': '16.6', 'groupId': 'OG000'}]}]}, {'title': 'Saliva', 'categories': [{'measurements': [{'value': '15', 'spread': '17.3', 'groupId': 'OG000'}]}]}, {'title': 'Shoulder', 'categories': [{'measurements': [{'value': '14', 'spread': '16.8', 'groupId': 'OG000'}]}]}, {'title': 'Speech', 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Swallowing', 'categories': [{'measurements': [{'value': '33.9', 'spread': '45.3', 'groupId': 'OG000'}]}]}, {'title': 'Taste', 'categories': [{'measurements': [{'value': '19.', 'spread': '9.6', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL last 7 days', 'categories': [{'measurements': [{'value': '46.8', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - QOL since 1 mo. before cancer', 'categories': [{'measurements': [{'value': '38.8', 'spread': '27.1', 'groupId': 'OG000'}]}]}, {'title': 'Global severity - Overall QOL', 'categories': [{'measurements': [{'value': '40.4', 'spread': '13.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 16.5 months, up to 48.9 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed UW-QOL assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '4.0', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '4.3', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week (N', 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4.5-7.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'categories': [{'measurements': [{'value': '3', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '5.1', 'spread': '3', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7.5-10.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week', 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10.5-13.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '4.5', 'spread': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week', 'categories': [{'measurements': [{'value': '5.0', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'categories': [{'measurements': [{'value': '5.0', 'spread': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'categories': [{'measurements': [{'value': '5.5', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13.5-16.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'General Activity', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '2', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Relationships', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Average pain', 'categories': [{'measurements': [{'value': '2', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Pain least in last week', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain right now', 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain Worst in last week', 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 16.5 months, up to 48.9 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients who completed BPI assessments.'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.\n\nTHOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.'}], 'classes': [{'title': 'Activity', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Appearance', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Clothes', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Messy', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Problems', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Sexual', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Social', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Sport', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Studying', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Working', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. 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The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. 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The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. 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The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. 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The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. 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The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. 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Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'timeFrame': 'Up to 4.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'timeFrame': '4.5-7.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'timeFrame': '7.5-10.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'timeFrame': '10.5-13.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'timeFrame': '13.5-16.5 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'University of Washington Quality of Life Questionnaire (UW-QOL)', 'timeFrame': 'after 16.5 months, up to 48.9 months', 'description': 'The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \\& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': 'Baseline', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': 'Up to 4.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': '4.5-7.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': '7.5-10.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': '10.5-13.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': '13.5-16.5 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Brief Pain Inventory (BPI)', 'timeFrame': 'after 16.5 months, up to 48.9 months', 'description': 'Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient\'s various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item).\n\nPain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe\n\nHigher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.'}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Up to 4.5 months', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': '4.5 - 7.5 months', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': '7.5-10.5 months', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': '10.5-13.5 months', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': '13.5-16.5 months', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'after 16.5 months, up to 48.9 months', 'description': "Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Radiation Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.', 'detailedDescription': 'This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy.\n\nPatients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy.\n\nInformation collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients ≥ 18 years of age\n* Karnofsky performance status \\> 70\n* Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx\n* No prior radiotherapy to the head and neck region.\n* No previous systemic chemotherapy or targeted therapy\n* Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.\n* Patients using standard therapies for cetuximab-induced acne-form rash will be included.\n\nExclusion Criteria:\n\n* Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies\n* Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator\n* Concurrent serious infection\n* Continued use of Niacin'}, 'identificationModule': {'nctId': 'NCT02384434', 'briefTitle': 'Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'HCC 18-128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low Level Laser Therapy', 'description': 'Non-invasive, cold laser output treatment.', 'interventionNames': ['Device: THOR Laser System for Low Level Laser Therapy (LLLT)']}], 'interventions': [{'name': 'THOR Laser System for Low Level Laser Therapy (LLLT)', 'type': 'DEVICE', 'description': 'Non-invasive, a cold laser output treatment.', 'armGroupLabels': ['Low Level Laser Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center - Shadyside Radiation Oncology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Heath Skinner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPMC Hillman Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heath Skinner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Heath Skinner', 'investigatorAffiliation': 'University of Pittsburgh'}}}}