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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04478851
Other study ID # HREBA.CC-20-0098
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2, 2020
Est. completion date December 31, 2027

Study information

Verified date March 2022
Source University of Calgary
Contact Nicole Culos-Reed, PhD
Phone +1 (403) 220-7540
Email nculosre@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

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

Sponsors (8)

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

Country where clinical trial is conducted

Canada, 

Outcome

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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