EXCEL: Exercise for Cancer to Enhance Living Well

Breast Cancer Clinical Trial

— EXCEL  

Official title:

Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478851
• Other study ID #: HREBA.CC-20-0098
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Cancer Caregivers
• Colon Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Prostate Cancer

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