EXCEL: Exercise for Cancer to Enhance Living Well (EXCEL)
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|ClinicalTrials.gov Identifier: NCT04478851|
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cancer Head and Neck Cancer Colon Cancer Breast Cancer Prostate Cancer Cancer Caregivers||Behavioral: Group Exercise Classes||Not Applicable|
As cancer survivorship numbers grow, a focus on positive health in survivorship is essential. Exercise is an evidence-based effective self-management strategy that benefits all cancer survivors (CS). However, the majority of research and the limited development of evidence-based clinical or community programs in exercise and cancer has been conducted almost exclusively in urban academic and clinical settings, with very limited implementation outreach to "hard to reach" CS.
In this proposed cancer exercise hybrid implementation effectiveness research, over 5 years we will use an integrated knowledge translation approach to move the current evidence-base that clearly supports the role of exercise in cancer survivorship, into sustainable and effective community-based or online settings that will optimize the delivery of exercise to rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise Oncology Survivorship (EOS) partnership model will result in a sustainable resource to support the implementation and delivery of exercise oncology programs in rural Canadian communities.
Investigators will work to develop lasting referral pathways between cancer care clinics and local fitness professionals. These fitness professionals will have additional cancer specific training to ensure they can effectively and safely deliver the program. Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming. If, due to COVID-19 public health restrictions, community based programming cannot occur, the exercise sessions will be delivered online by fitness professionals.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Hybrid implementation effectiveness study|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life|
|Actual Study Start Date :||September 2, 2020|
|Estimated Primary Completion Date :||December 31, 2027|
|Estimated Study Completion Date :||December 31, 2027|
All participants will be involved in group exercise classes, twice a week for 12 weeks.
Behavioral: Group Exercise Classes
The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.
- Physical Activity Minutes Per Week [ Time Frame: Baseline to one-year ]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.
- Body Composition [ Time Frame: Baseline to post 12-week exercise intervention ]Change in body mass index (BMI)
- Aerobic Endurance [ Time Frame: Baseline to post 12-week exercise intervention ]Change in 6-minute walk test (m) or 2 minute step test (steps) results
- Upper extremity grip strength [ Time Frame: Baseline to post 12-week exercise intervention ]Change in hand-grip dynamometry (kg)
- Functional performance test [ Time Frame: Baseline to post 12-week exercise intervention ]Change in sit-to-stand (number of repetitions in 30 seconds)
- Upper extremity flexibility [ Time Frame: Baseline to post 12-week exercise intervention ]Change in active shoulder flexion range of motion (degrees)
- Lower extremity flexibility [ Time Frame: Baseline to post 12-week exercise intervention ]Change in sit-and-reach test (cm)
- Balance [ Time Frame: Baseline to post 12-week exercise intervention ]Change in one legged stance test (seconds)
- Symptom tracking [ Time Frame: Baseline to one year ]Change in fatigue, mood, and QOL, recorded via m-Health app
- Cancer related symptoms [ Time Frame: Baseline to one year ]
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.
- Subjective reporting of average weekly physical activity [ Time Frame: Baseline to one year ]Change in Godin Leisure Time Exercise Questionnaire
- General Health-related Quality of Life [ Time Frame: Baseline to one year ]
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.
- Fatigue [ Time Frame: Baseline to one year ]
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".
- General well-being [ Time Frame: Baseline to one year ]
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".
- Cognition [ Time Frame: Baseline to one year ]
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).
- Barriers and facilitators to exercise participation [ Time Frame: Baseline to one year ]Change in Exercise Barriers and Facilitators questionnaire
- Exercise adherence [ Time Frame: Baseline to one year ]Adherence to exercise programming (attendance at sessions)
- Program implementation and evaluation [ Time Frame: Baseline to one year ]RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478851
|Contact: Nicole Culos-Reed, PhD||+1 (403) firstname.lastname@example.org|
|Contact: Julianna Dreger, M.ClinExPhys||+1 (403) email@example.com|
|Health and Wellness Lab, University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N 1N4|
|Contact: Nicole Culos-Reed, PhD +1 403-210-8482 firstname.lastname@example.org|
|Contact: Julianna Dreger, M.ClinExPhys +1 403-210-8482 email@example.com|
|University of Alberta||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2G4|
|Contact: Margaret L McNeely, PhD|
|Canada, Nova Scotia|
|Dalhousie University||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3H 4R2|
|Contact: Melanie Keats, PhD|
|Principal Investigator:||Nicole Culos-Reed, PhD||University of Calgary|
|Principal Investigator:||Margaret L McNeely, PhD||University of Alberta|
|Principal Investigator:||Melanie Keats, PhD||Dalhousie University|