protocolSection identificationModule nctId: NCT06323707, orgStudyIdInfo id: IMPACT, briefTitle: The IMPACT Implementation-Effectiveness Trial, acronym: IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2027-03-15, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Canadian Cancer Society (CCS), collaborators name: Hamilton Health Sciences Corporation, collaborators name: Niagara Health System, descriptionModule briefSummary: More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 129, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Self-management e-module, outcomesModule primaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Level of exercise knowledge, secondaryOutcomes measure: Level of exercise knowledge, secondaryOutcomes measure: Level of exercise knowledge, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Cardiovascular outcomes - Blood pressure, secondaryOutcomes measure: Cardiovascular outcomes - Blood pressure, secondaryOutcomes measure: Cardiovascular outcomes - Blood pressure, secondaryOutcomes measure: Cardiovascular outcomes - Heart rate, secondaryOutcomes measure: Cardiovascular outcomes - Heart rate, secondaryOutcomes measure: Cardiovascular outcomes - Heart rate, secondaryOutcomes measure: Health care utilization, secondaryOutcomes measure: Health care utilization, secondaryOutcomes measure: Health care utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False