Breast Cancer Clinical Trial
— EXCELOfficial title:
Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life
Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - have a diagnosis of cancer - are over the age of 18 years - are able to participate in mild levels of activity - are about to have treatment, are currently having treatment, or have had cancer treatment within the last 5 years - can read/write in English - can access online programs, if necessary, to participate in the exercise programs. Exclusion Criteria: - unable to read/write in English - are unable to participate in exercise - for online programs, do not have internet or computer access |
Country | Name | City | State |
---|---|---|---|
Canada | Health and Wellness Lab, University of Calgary | Calgary | Alberta |
Canada | University of Alberta | Edmonton | Alberta |
Canada | Dalhousie University | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Alberta Health Services, Dalhousie University, Memorial University of Newfoundland, University Health Network, Toronto, University of Alberta, University of British Columbia, University of Prince Edward Island |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity Minutes Per Week | Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker. | Baseline to one-year | |
Secondary | Body Composition | Change in body mass index (BMI) | Baseline to post 12-week exercise intervention | |
Secondary | Aerobic Endurance | Change in 6-minute walk test (m) or 2 minute step test (steps) results | Baseline to post 12-week exercise intervention | |
Secondary | Upper extremity grip strength | Change in hand-grip dynamometry (kg) | Baseline to post 12-week exercise intervention | |
Secondary | Functional performance test | Change in sit-to-stand (number of repetitions in 30 seconds) | Baseline to post 12-week exercise intervention | |
Secondary | Upper extremity flexibility | Change in active shoulder flexion range of motion (degrees) | Baseline to post 12-week exercise intervention | |
Secondary | Lower extremity flexibility | Change in sit-and-reach test (cm) | Baseline to post 12-week exercise intervention | |
Secondary | Balance | Change in one legged stance test (seconds) | Baseline to post 12-week exercise intervention | |
Secondary | Symptom tracking | Change in fatigue, mood, and QOL, recorded via m-Health app | Baseline to one year | |
Secondary | Cancer related symptoms | Change in Edmonton Symptom Assessment Scale.
- scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced. |
Baseline to one year | |
Secondary | Subjective reporting of average weekly physical activity | Change in Godin Leisure Time Exercise Questionnaire | Baseline to one year | |
Secondary | General Health-related Quality of Life | Change in EuroQual - 5Dimensions (EQ-5D) tool
- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable. |
Baseline to one year | |
Secondary | Fatigue | Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much". |
Baseline to one year | |
Secondary | General well-being | Change in Functional Assessment of Cancer Therapy - General subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much". |
Baseline to one year | |
Secondary | Cognition | Change in Functional Assessment of Cancer Therapy - Cognitive subscale
- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms). |
Baseline to one year | |
Secondary | Barriers and facilitators to exercise participation | Change in Exercise Barriers and Facilitators questionnaire | Baseline to one year | |
Secondary | Exercise adherence | Adherence to exercise programming (attendance at sessions) | Baseline to one year | |
Secondary | Program implementation and evaluation | RE-AIM: program reach, effectiveness, adoption, implementation and maintenance | Baseline to one year |
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