Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02836769
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2015-12-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sara.mcewen@sunnybrook.ca', 'phone': '416-226-6780', 'title': 'Dr. Sara McEwen', 'phoneExt': '7957', 'organization': 'Sunnybrook Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study did not include a control group and it is not known whether the improvements are due to the intervention, time, or other factors. Results from a single hospital may not be generalizable to other head and neck populations.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected during the 15 months when study participants were enrolled.', 'description': 'The risk of serious adverse events, mortality, and other adverse events was low because the study tested a behavioural intervention. Definitions of adverse events are in alignment with the Clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design\n\nRehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design\n\nRehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.'}], 'classes': [{'title': 'Mean difference (post - pre)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Mean difference (follow-up - pre)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '12.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A) 1 week post-intervention, B) 1-2 months post intervention', 'description': 'Cancer-specific self-report measure of quality of life, higher scores indicate higher self-reported quality of life. Scores can range from 0 to 148. Changes in overall score as well as subsets will be evaluated for evidence of impact of intervention.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Medical Outcome Short Form (36) Health Survey - (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design\n\nRehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.'}], 'classes': [{'title': 'PCS - Mean difference (post - pre)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'PCS - Mean Difference (follow-up - pre)', 'categories': [{'measurements': [{'value': '6.7', 'spread': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'MCS - Mean difference (post - pre)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'MCS - Mean Difference (follow-up - pre)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '7.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A) 1 week post-intervention, B) 1-2 months post intervention', 'description': 'Self-report quality of life questionnaire. Higher scores indicate a higher self-reported quality of life. The Physical Composite Score (PCS) and the Mental Composite Score (MCS) are reported. Scores range from 0 to 100 for each individual item on the scale. These scores are then converted into composite totals based on the scoring system provided with the outcome measure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Goal Performance, Satisfaction, and Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design\n\nRehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.'}], 'classes': [{'title': 'Performance (post - pre)', 'categories': [{'measurements': [{'value': '16.6', 'spread': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Performance (follow-up - pre)', 'categories': [{'measurements': [{'value': '37.3', 'spread': '31.2', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction (post - pre)', 'categories': [{'measurements': [{'value': '26.9', 'spread': '35.4', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction (follow-up- pre)', 'categories': [{'measurements': [{'value': '39.2', 'spread': '32.6', 'groupId': 'OG000'}]}]}, {'title': 'Self-efficacy (post - pre)', 'categories': [{'measurements': [{'value': '18.4', 'spread': '27.1', 'groupId': 'OG000'}]}]}, {'title': 'Self-efficacy (follow-up- pre)', 'categories': [{'measurements': [{'value': '17.1', 'spread': '35.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A) 1 week post-intervention, B) 1-2 months post intervention', 'description': 'Participants completed the Brief Rehabilitation Assessment for Survivors Of Head And Neck Cancer (BRASH), a self report tool where participants rate their current performance, satisfaction with self-selected rehab goals, and rate their confidence in their ability to achieve each goal. Higher scores indicate greater self-reported, performance, satisfaction, and self-efficacy. Scores for each of confidence, performance, and satisfaction can range from 0 to 100. Each category is then compared to itself and the change calculated by subtracting the earlier score from the latter.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design\n\nRehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Completed Post-test Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Medical withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design\n\nRehabilitation Consult (RC): The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.8', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weeks post-treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.2', 'spread': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Had rehab goals', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-11', 'size': 890022, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-09-06T08:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2015-12-04', 'resultsFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-23', 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N)', 'timeFrame': 'A) 1 week post-intervention, B) 1-2 months post intervention', 'description': 'Cancer-specific self-report measure of quality of life, higher scores indicate higher self-reported quality of life. Scores can range from 0 to 148. Changes in overall score as well as subsets will be evaluated for evidence of impact of intervention.'}, {'measure': 'Change in Medical Outcome Short Form (36) Health Survey - (SF-36)', 'timeFrame': 'A) 1 week post-intervention, B) 1-2 months post intervention', 'description': 'Self-report quality of life questionnaire. Higher scores indicate a higher self-reported quality of life. The Physical Composite Score (PCS) and the Mental Composite Score (MCS) are reported. Scores range from 0 to 100 for each individual item on the scale. These scores are then converted into composite totals based on the scoring system provided with the outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Change in Goal Performance, Satisfaction, and Self-efficacy', 'timeFrame': 'A) 1 week post-intervention, B) 1-2 months post intervention', 'description': 'Participants completed the Brief Rehabilitation Assessment for Survivors Of Head And Neck Cancer (BRASH), a self report tool where participants rate their current performance, satisfaction with self-selected rehab goals, and rate their confidence in their ability to achieve each goal. Higher scores indicate greater self-reported, performance, satisfaction, and self-efficacy. Scores for each of confidence, performance, and satisfaction can range from 0 to 100. Each category is then compared to itself and the change calculated by subtracting the earlier score from the latter.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Head and neck cancer', 'Quality of life', 'self-efficacy'], 'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'availIpds': [{'url': 'http://www.implementationscience.com/content/10/1/6', 'type': 'Study Protocol', 'comment': 'Publication of the initial project protocol'}, {'url': 'http://link.springer.com/article/10.1007%2Fs00520-015-3021-1', 'type': 'Clinical Study Report', 'comment': 'Publication based on findings from focus groups used to create the intervention in this study'}]}, 'descriptionModule': {'briefSummary': 'Although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. Therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for HNC survivors and personalized action plans to meet those goals; and to provide support to HNC survivors for the implementation and evaluation of action plans. This project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.', 'detailedDescription': "A RC for survivors of head and neck cancer (HNC) was developed in collaboration with an Advisory Panel that includes survivors, family members, health care professionals, and health system representatives. This phase of the study aims to conduct a pilot evaluation of the RC using a mixed method, single group study with a convenience sample of approximately 35 survivors of HNC post primary cancer treatment, recruited from the Princess Margaret Cancer Center HNC clinics. In addition to the RC intervention, participants will be required to attend 3 research assessments (pre intervention, post intervention, and 1 month follow-up) that are a combination of face-to-face visits and telephone calls.\n\nQuantitative data analysis will be exploratory and descriptive, and effect sizes will be calculated for all outcomes to help plan for a future, controlled trial. Means, standard deviations, and Cohen's d effect size will be calculated for normally distributed data. For non-normally distributed data, medians, ranges, and a nonparametric effect size r will be calculated. For qualitative analysis, all interviews will be audio recorded, transcribed verbatim, and analyzed using a two-phased, hybrid approach that is both deductive and inductive. Findings will be summarized and reported to the Advisory Panel, who will then make recommendations regarding any additional modifications to the RC. The research team will make final decisions about RC modifications and will finalize a version for future evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult survivors of HNC who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months.\n\nExclusion Criteria:\n\n* Lack of English fluency,\n* Cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and\n* Known active cancer.'}, 'identificationModule': {'nctId': 'NCT02836769', 'acronym': 'HNC-RC', 'briefTitle': 'Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Development and Pilot Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer', 'orgStudyIdInfo': {'id': '246-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation Consult (RC)', 'description': 'Pilot testing: single group pre-post design', 'interventionNames': ['Behavioral: Rehabilitation Consult (RC)']}], 'interventions': [{'name': 'Rehabilitation Consult (RC)', 'type': 'BEHAVIORAL', 'description': 'The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.', 'armGroupLabels': ['Rehabilitation Consult (RC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre, Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Sara McEwen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sunnybrook Research Institute, St. John's Rehab Program"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Princess Margaret Hospital, Canada', 'class': 'OTHER'}, {'name': 'Toronto General Hospital', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}