Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT03030859
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2016-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jiedeng@nursing.upenn.edu', 'phone': '215-573-2393', 'title': 'Jie Deng, PhD, PI', 'organization': 'University of Pennsylvania School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a pilot study with the small number of participants.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 12 months.', 'description': 'No adverse event was reported during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Group I (Usual Care)', 'description': 'Patients receive monthly automated system telephone call for 12 months.\n\nUsual Care: Undergo usual care only', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II (Usual Care Plus LEF-SCP)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.\n\nUsual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group III (Usual Care Plus LEF-SCP Plus Follow-Up)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.\n\nUsual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group II (Usual Care Plus LEF-SCP)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.\n\nUsual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos'}, {'id': 'OG001', 'title': 'Group III (Usual Care Plus LEF-SCP Plus Follow-Up)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.\n\nUsual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Following 3 weeks of the LEF-SCP sessions', 'description': 'Feasibility of the LEF-SCP was evaluated by number of participants that completed the self-care skill training sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility of the LEF-SCP (Motivational Interviewing Sessions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group II (Usual Care Plus LEF-SCP)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.\n\nUsual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos'}, {'id': 'OG001', 'title': 'Group III (Usual Care Plus LEF-SCP Plus Follow-Up)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.\n\nUsual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Following 3 weeks of motivational interviewing sessions', 'description': 'Feasibility of the LEF-SCP was evaluated by number of participants that completed the motivational interviewing sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Usual Care'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Usual Care Plus LEF-SCP'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Usual Care Plus LEF-SCP Plus Follow-Up'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-1.01', 'upperLimit': '0.80'}, {'value': '-2.35', 'groupId': 'OG001', 'lowerLimit': '-3.51', 'upperLimit': '-1.19'}, {'value': '-2.25', 'groupId': 'OG002', 'lowerLimit': '-3.91', 'upperLimit': '-0.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months post-intervention', 'description': 'Change in total severity of external LEF from baseline to 12 months post-intervention. A larger change in this score means more reduction in the severity of external LEF,\n\nExternal LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preliminary Efficacy of the LEF-SCP (Symptom Burden)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Usual Care'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Usual Care Plus LEF-SCP'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Usual Care Plus LEF-SCP Plus Follow-Up'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '0.19'}, {'value': '-0.73', 'groupId': 'OG001', 'lowerLimit': '-1.21', 'upperLimit': '-0.24'}, {'value': '-0.53', 'groupId': 'OG002', 'lowerLimit': '-1.06', 'upperLimit': '-0.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months post-intervention', 'description': 'Change in symptom burden score from baseline to 12 months post-intervention. A larger change in this score means decreased symptom burden.\n\nSymptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (soft tissue and neurologic toxicity) score is reported here.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preliminary Efficacy of the LEF-SCP (Self-Efficacy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Usual Care'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Usual Care Plus LEF-SCP'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Usual Care Plus LEF-SCP Plus Follow-Up'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '-1.33', 'upperLimit': '3.85'}, {'value': '4.71', 'groupId': 'OG001', 'lowerLimit': '1.21', 'upperLimit': '8.21'}, {'value': '4.85', 'groupId': 'OG002', 'lowerLimit': '0.12', 'upperLimit': '9.57'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12 months post-intervention', 'description': 'Change in self-efficacy score from baseline to 12 months post-intervention. A larger change in this score means increased self-efficacy.\n\nSelf-efficacy is assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) (8-item). Higher scores (score ranging from 8-40) indicate greater self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I (Usual Care)', 'description': 'Participants received usual care.'}, {'id': 'FG001', 'title': 'Group II (Usual Care Plus LEF-SM Program)', 'description': 'Participants received usual care and LEF-SM Program.'}, {'id': 'FG002', 'title': 'Group III (Usual Care Plus LEF-SM Program Plus Follow-Up With a Lymphedema Therapist)', 'description': 'Participants received usual care plus LEF-SM Program plus follow-up with a lymphedema therapist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I (Usual Care)', 'description': 'Patients receive monthly automated system telephone call for 12 months.\n\nUsual Care: Undergo usual care only'}, {'id': 'BG001', 'title': 'Group II (Usual Care Plus LEF-SCP)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.\n\nUsual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos'}, {'id': 'BG002', 'title': 'Group III (Usual Care Plus LEF-SCP Plus Follow-Up)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.\n\nUsual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '60', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '60', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '60', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-10', 'size': 144211, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-27T19:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2016-12-30', 'resultsFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2017-01-22', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-15', 'studyFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)', 'timeFrame': 'Following 3 weeks of the LEF-SCP sessions', 'description': 'Feasibility of the LEF-SCP was evaluated by number of participants that completed the self-care skill training sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.'}, {'measure': 'Feasibility of the LEF-SCP (Motivational Interviewing Sessions)', 'timeFrame': 'Following 3 weeks of motivational interviewing sessions', 'description': 'Feasibility of the LEF-SCP was evaluated by number of participants that completed the motivational interviewing sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.'}, {'measure': 'Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)', 'timeFrame': 'at 12 months post-intervention', 'description': 'Change in total severity of external LEF from baseline to 12 months post-intervention. A larger change in this score means more reduction in the severity of external LEF,\n\nExternal LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3).'}, {'measure': 'Preliminary Efficacy of the LEF-SCP (Symptom Burden)', 'timeFrame': 'at 12 months post-intervention', 'description': 'Change in symptom burden score from baseline to 12 months post-intervention. A larger change in this score means decreased symptom burden.\n\nSymptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (soft tissue and neurologic toxicity) score is reported here.'}, {'measure': 'Preliminary Efficacy of the LEF-SCP (Self-Efficacy)', 'timeFrame': 'at 12 months post-intervention', 'description': 'Change in self-efficacy score from baseline to 12 months post-intervention. A larger change in this score means increased self-efficacy.\n\nSelf-efficacy is assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) (8-item). Higher scores (score ranging from 8-40) indicate greater self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Lymphedema', 'Fibrosis']}, 'referencesModule': {'references': [{'pmid': '40773982', 'type': 'DERIVED', 'citation': 'Deng J, Murphy BA, Andersen LP, McMenamin E, Lukens JN, Cohn JC, Rajasekaran K, Quinn RJ, Spinelli BA, Lin A. Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot randomized controlled trial. Oral Oncol. 2025 Sep;168:107556. doi: 10.1016/j.oraloncology.2025.107556. Epub 2025 Aug 6.'}, {'pmid': '36348346', 'type': 'DERIVED', 'citation': 'Deng J, Lukens JN, Cohn JC, McMenamin E, Murphy B, Spinelli BA, Murphy N, Steinmetz AK, Landriau MA, Lin A. Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies. Trials. 2022 Nov 8;23(1):927. doi: 10.1186/s13063-022-06804-w.'}, {'pmid': '31882012', 'type': 'DERIVED', 'citation': 'Deng J, Dietrich MS, Murphy B. Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):775. doi: 10.1186/s13063-019-3819-0.'}]}, 'descriptionModule': {'briefSummary': 'This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care activities for managing chronic swelling and tough/tight tissues in the head and neck region.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To complete development of a self-care program focusing on lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors (LEF-self-care program \\[SCP\\]) with the goal of improving LEF associated outcomes when compared to usual care alone. (Stage I)\n\nII. To determine the feasibility of a program of LEF-SCP with or without follow-up to usual care for HNC survivors with LEF, specifically to: 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction. (Stage II)\n\nIII. To determine if the LEF-SCP with or without follow-up enhances self-efficacy and adherence compared to usual care in HNC survivors with LEF. (Stage II)\n\nIV. To determine the preliminary efficacy of the LEF-SCP with or without follow-up as compared to usual care for the following outcomes: 1) LEF progression; 2) symptom burden; and 3) functional status. (Stage II)\n\nOUTLINE:\n\nProject Stage I: Patients undergo a training session with the study lymphedema therapist and review the educational manual and videos for the development of all three components of the LEF self-care program.\n\nProject Stage II: Patients are randomized to 1 of 3 groups.\n\nGROUP I: Patients will receive usual care only, without any additional interventions.\n\nGROUP II: Patients undergo LEF-SCP training comprising of motivational interview (MI) session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.\n\nGROUP III: Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.\n\nAfter completion of study, patients are followed up at 3, 6, 9, and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post HNC primary treatment\n* No evidence of cancer (NED)\n* No more than 6 months after completion of initial lymphedema therapy for head and neck lymphedema\n* \\> 18 years of age\n* Ability to understand English in order to complete questionnaires\n* Able to complete the onsite training and home self-care activities for LEF management\n* Able to provide informed consent\n\nExclusion Criteria:\n\n• Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT03030859', 'briefTitle': 'Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis', 'orgStudyIdInfo': {'id': 'IRB# 828744'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01901', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (Usual Care)', 'description': 'Patients receive usual care only, without any additional interventions.', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (Usual Care plus LEF-SCP)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.', 'interventionNames': ['Other: Usual Care plus LEF-SCP']}, {'type': 'EXPERIMENTAL', 'label': 'Group III (Usual Care plus LEF-SCP plus Follow-Up)', 'description': 'Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.', 'interventionNames': ['Other: Usual Care plus LEF-SCP plus Follow-up']}], 'interventions': [{'name': 'Usual Care', 'type': 'OTHER', 'description': 'Undergo usual care only', 'armGroupLabels': ['Group I (Usual Care)']}, {'name': 'Usual Care plus LEF-SCP', 'type': 'OTHER', 'description': 'Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos', 'armGroupLabels': ['Group II (Usual Care plus LEF-SCP)']}, {'name': 'Usual Care plus LEF-SCP plus Follow-up', 'type': 'OTHER', 'description': 'Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist', 'armGroupLabels': ['Group III (Usual Care plus LEF-SCP plus Follow-Up)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jie Deng, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jie Deng', 'investigatorAffiliation': 'University of Pennsylvania'}}}}