Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-04-16 @ 1:10 AM
Study NCT ID:
NCT03087461
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Recruitment Rate: percentage of eligible patients recruited', 'timeFrame': 'Baseline', 'description': 'A recruitment log will be kept, detailing reasons for non-participation.'}, {'measure': 'Intervention Retention Rate: percentage of consented participants who completed the intervention', 'timeFrame': 'Post-intervention (2 months post baseline)', 'description': 'Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log'}, {'measure': 'Intervention Adherence Rate: percentage of total intervention sessions attended', 'timeFrame': 'Post-intervention (2 months post baseline)', 'description': 'Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)', 'description': 'Functional Assessment of Cancer Therapy-Breast'}, {'measure': 'Exercise knowledge', 'timeFrame': 'Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)', 'description': 'Theory of planned behaviour questionnaire'}, {'measure': 'Exercise behaviour', 'timeFrame': 'Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)', 'description': 'Theory of planned behaviour questionnaire'}, {'measure': 'Health status', 'timeFrame': 'Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)', 'description': 'European Quality of Life-Five Dimension (EQ-5D)'}, {'measure': 'Use of health care services', 'timeFrame': 'Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)', 'description': 'Piloted form assessing doctor visits, procedures, medication use, missed days of work'}, {'measure': 'Physical Activity Level', 'timeFrame': 'Baseline, post intervention, 2 and 4 month follow up', 'description': 'Godin Leisure Time Physical Activity Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31168711', 'type': 'DERIVED', 'citation': 'Smith-Turchyn J, Richardson J, Tozer R, McNeely M, Thabane L. Bridging the gap: incorporating exercise evidence into clinical practice in breast cancer care. Support Care Cancer. 2020 Feb;28(2):897-905. doi: 10.1007/s00520-019-04897-9. Epub 2019 Jun 5.'}]}, 'descriptionModule': {'briefSummary': "Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's life for years after treatment has ended. Research shows that regular exercise limits many of these side effects. However, less than 30% of BC survivors regularly exercise due to many barriers that include patients being unaware of the benefits of exercise, health professionals facing institutional, personal, and patient-related barriers to promoting exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that focus on accessible exercise interventions and education by physiotherapists. For this project, a pilot study is needed as the first step in order to assess process and resource variables before implementation of a large-scale intervention.\n\nThe primary objective of this pilot trial is to assess the feasibility of conducting a larger trial to evaluate the effects of a novel KT intervention using exercise and self-management versus usual care among BC survivors. The secondary objective is to determine preliminary estimates of effects of the KT intervention of exercise plus self-management (SM) program versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related quality of life and (c) resource utilization, among BC survivors over a four month period.", 'detailedDescription': 'Study Design: Pilot randomized controlled trial. Eligibility: Women older than 18 years who are currently undergoing chemotherapy treatment for BC.\n\nIntervention: The intervention group includes an 8-session multi-component intervention with a structured aerobic exercise program plus SM supervised by a physiotherapist.\n\nSetting: Outpatient-Juravinski Cancer Centre in Hamilton, ON. Control: Usual care. Randomization: Participants will be randomly allocated using a 1:1 allocation ratio to receive the intervention of structured exercise plus SM program or usual care.\n\nSample size: The study will recruit n=12 number of participants/group for a total of 24 in both groups.\n\nAnalysis: A blinded assessor will assess outcomes at baseline, post intervention, at 2- and 4-month follow up. Intervention feasibility and effectiveness will be assessed using descriptive statistics and analysis of covariance for continuous outcomes.\n\nAnticipated Impact: This study aims to assess the feasibility of a larger trial to determine effective ways to close the current KT gap and increase exercise awareness for women with BC. This project will assess process and resource variables before implementation of a larger scale intervention. Together, the overall project goal is to promote sustainable exercise behaviour to help manage the burden of BC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community-dwelling, English-speaking women, over 18 years, who are currently undergoing chemotherapy for Stage 1-3 BC and have been cleared by their oncologist to participate in moderate intensity aerobic exercise\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they have another chronic disease, cognitive impairment or injury that prevents them from participating independently in moderate intensity exercise'}, 'identificationModule': {'nctId': 'NCT03087461', 'briefTitle': 'Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario', 'orgStudyIdInfo': {'id': 'HamiltonHSC-JS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention group will receive a multi-component KT intervention. This will include exercise and self-management components.\n\nThe exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation.\n\nThe SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions.', 'interventionNames': ['Behavioral: Exercise and self-management']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Control group receiving usual care (no exercise or self-management education within the institution).'}], 'interventions': [{'name': 'Exercise and self-management', 'type': 'BEHAVIORAL', 'description': 'The intervention will include aerobic exercise and self-management education using technology.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S1C7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Jenna Smith-Turchyn, PT, PhD(c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Jenna Smith', 'investigatorAffiliation': 'Hamilton Health Sciences Corporation'}}}}