EXCEL: Exercise for Cancer to Enhance Living Well

Sponsor

University of Calgary (Other)

Overall Status

Recruiting

CT.gov ID

NCT04478851

Collaborator

University of Alberta (Other), Dalhousie University (Other), Alberta Health services (Other), University Health Network, Toronto (Other), Memorial University of Newfoundland (Other), University of British Columbia (Other), University of Prince Edward Island (Other)

1,500

Enrollment

Locations

Arm

87.9

Anticipated Duration (Months)

500

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Head and Neck Cancer Colon Cancer Breast Cancer Prostate Cancer Cancer Caregivers	Behavioral: Group Exercise Classes	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Hybrid implementation effectiveness studyHybrid 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 :

Sep 2, 2020

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.

Arm

Intervention/Treatment

Experimental: Intervention

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.

Outcome Measures

Primary Outcome Measures

Physical Activity Minutes Per Week [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.

Secondary Outcome Measures

Body Composition [Baseline to post 12-week exercise intervention]
Change in body mass index (BMI)
Aerobic Endurance [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 [Baseline to post 12-week exercise intervention]
Change in hand-grip dynamometry (kg)
Functional performance test [Baseline to post 12-week exercise intervention]
Change in sit-to-stand (number of repetitions in 30 seconds)
Upper extremity flexibility [Baseline to post 12-week exercise intervention]
Change in active shoulder flexion range of motion (degrees)
Lower extremity flexibility [Baseline to post 12-week exercise intervention]
Change in sit-and-reach test (cm)
Balance [Baseline to post 12-week exercise intervention]
Change in one legged stance test (seconds)
Symptom tracking [Baseline to one year]
Change in fatigue, mood, and QOL, recorded via m-Health app
Cancer related symptoms [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 [Baseline to one year]
Change in Godin Leisure Time Exercise Questionnaire
General Health-related Quality of Life [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 [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 [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 [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 [Baseline to one year]
Change in Exercise Barriers and Facilitators questionnaire
Exercise adherence [Baseline to one year]
Adherence to exercise programming (attendance at sessions)
Program implementation and evaluation [Baseline to one year]
RE-AIM: program reach, effectiveness, adoption, implementation and maintenance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health and Wellness Lab, University of Calgary	Calgary	Alberta	Canada	T2N 1N4
2	University of Alberta	Edmonton	Alberta	Canada	T6G 2G4
3	Dalhousie University	Halifax	Nova Scotia	Canada	B3H 4R2