Exercise Program for Cancer Survivors

(EXCEL Trial)

Recruiting at 2 trial locations

Overseen By Julianna Dreger, M.ClinExPhys

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Unable to exercise, No internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 26

Duration: 12 weeks

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise programs for cancer survivors.

What data supports the effectiveness of the treatment Group Exercise Classes for Cancer Survivors?

Research shows that exercise is a safe and effective way to support cancer care, improving physical fitness, well-being, and quality of life for cancer survivors. Exercise programs, especially in group settings, can also enhance psychological health by reducing anxiety and depression and increasing social connectedness. ^{1 2 3 4 5}

Is exercise safe for cancer survivors?

Exercise is considered a safe and effective supportive care resource for individuals living with and beyond cancer, improving physical fitness, well-being, and quality of life. ^{2 6 7 8 9}

How is the EXCEL Program treatment different from other treatments for cancer survivors?

The EXCEL Program is unique because it focuses on providing accessible group exercise classes specifically designed for cancer survivors, especially those in rural and remote areas, to improve their physical fitness, well-being, and quality of life. Unlike traditional treatments that may focus on medication or hospital-based care, this program emphasizes community-based exercise as a supportive care resource. ^{2 6 10 11 12}

Research Team

Melanie Keats, PhD

Principal Investigator

Dalhousie University

Nicole Culos-Reed, PhD

Principal Investigator

University of Calgary

Margaret L McNeely, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults over 18 who are about to start, currently undergoing, or have completed cancer treatment within the last 5 years. Participants must be able to read/write in English and access online programs if needed. They should be capable of mild physical activity and have a diagnosis of cancer.

Inclusion Criteria

I can do light activities without significant difficulty.

Able to access online programs, if necessary, to participate in the exercise programs

I have been diagnosed with cancer.

Exclusion Criteria

No internet or computer access for online programs

Unable to read/write in English

I cannot participate in physical activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Exercise Safety Screening and Fitness Testing

Eligible participants are screened for exercise safety and undergo fitness testing to be triaged to appropriate exercise programming

1-2 weeks

1-2 visits (in-person or virtual)

Treatment

Participants engage in group exercise classes, twice a week for 12 weeks

12 weeks

24 visits (in-person or virtual)

Follow-up

Participants are monitored for exercise adherence, cognitive changes, and other health outcomes

up to 1 year

Periodic assessments (in-person or virtual)

Treatment Details

Interventions

• Group Exercise Classes

Trial Overview EXCEL aims to provide community or online exercise programs specifically designed for rural and under-served cancer survivors. The goal is to help participants become life-long exercisers by offering tailored exercise opportunities that they might not otherwise have.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

All participants will be involved in group exercise classes, twice a week for 12 weeks.

Group Exercise Classes is already approved in Canada for the following indications:

Approved in Canada as EXCEL Program for:

• Improving physical function and exercise behavior in cancer survivors
• Enhancing overall physical activity levels, health, and quality of life

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

University of Prince Edward Island

Collaborator

Trials

17

Recruited

97,300+

Findings from Research

A 14-week team triathlon training program significantly improved aerobic capacity (measured by VO2 max) and quality of life in female breast cancer survivors, with notable improvements in physical strength and walking endurance.

Participants showed lasting benefits, as improvements in strength and walking distance were maintained even 6 months after completing the program, suggesting that structured exercise can lead to healthier lifestyles for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triathlon training for women breast cancer survivors: feasibility and initial efficacy. Ng, AV., Cybulski, AN., Engel, AA., et al.[2018]

The EXCEL study aims to improve access to exercise oncology programs for approximately 1500 individuals living with cancer in rural and remote areas over a 5-year period, highlighting the importance of exercise as a safe and effective supportive care resource.

Participants will engage in a 12-week online multimodal exercise intervention, with outcomes assessed to evaluate the program's reach and effectiveness, ensuring that all cancer patients can benefit from improved physical fitness and quality of life regardless of their location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). Culos-Reed, N., Wagoner, CW., Dreger, J., et al.[2023]

Multidisciplinary, exercise-based rehabilitation programs for cancer survivors significantly improve muscle strength and functional capacity, as evidenced by increased performance in exercises like the chest press and sit-to-stand tests, based on a systematic review of 17 trials involving 1,962 participants.

These rehabilitation programs also help reduce depression levels among participants, with a notable decrease in scores on the Hospital Anxiety and Depression Scale, indicating positive psychosocial outcomes compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary, exercise-based oncology rehabilitation programs improve patient outcomes but their effects on healthcare service-level outcomes remain uncertain: a systematic review. Dennett, AM., Sarkies, M., Shields, N., et al.[2021]

Regular and vigorous physical exercise can reduce cancer incidence by up to 40%, particularly for breast and colorectal cancers, and significantly improves survivorship by 50%-60% post-diagnosis, especially in breast and colorectal cancer patients.

Exercise serves as a critical adjuvant therapy for cancer patients, enhancing treatment outcomes by improving surgical results, managing side effects of therapies, and increasing muscle mass and fitness without raising testosterone levels, thus mitigating adverse effects of hormone therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in prevention and management of cancer. Newton, RU., Galvão, DA.[2022]

Regular physical exercise is associated with a reduced risk of developing colorectal and breast cancer, and may also lower the risk for prostate, endometrial, and lung cancers, based on a review of recent literature.

Exercise is beneficial for cancer survivors, aiding in recovery from treatment and potentially extending survival, although specific guidelines on the optimal amount, type, and intensity of exercise are still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cancer. Rajarajeswaran, P., Vishnupriya, R.[2021]

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

The study involved 63 breast cancer survivors across 66 group exercise counseling sessions, revealing that while a breast cancer diagnosis creates a common bond, factors like age and expectations can hinder group cohesion.

Key barriers to adherence included feelings of risk for cancer recurrence and people-pleasing behavior, highlighting the need for mental health referrals and effective behavioral modification techniques in group settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Rogers, LQ., Vicari, S., Courneya, KS.[2021]

A study involving 70 endometrial cancer survivors revealed that common barriers to participating in lifestyle interventions included time constraints, resource costs, and doubts about maintaining weight loss, while facilitators included the chance to connect with other survivors and a focus on health rather than just weight loss.

Post-COVID-19, 67% of survivors reported worsening physical activity, dietary choices, and mental health, highlighting the need for targeted interventions to improve their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed-method approach to informing a lifestyle intervention to improve the survivorship of patients with endometrial cancer. Armbruster, SD., Brow, K., Locklear, T., et al.[2023]

In a study involving 26 post-treatment breast cancer survivors, both a group dynamics-based exercise intervention and a personal training intervention led to significant improvements in physical activity and fitness over an eight-week period.

The group dynamics-based exercise intervention was particularly effective, resulting in greater enhancements in overall quality of life compared to the personal training approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group Dynamics-Based Exercise Versus Personal Training in Breast Cancer Survivors. Leach, HJ., Covington, KR., Voss, C., et al.[2022]

Community-based exercise programs for cancer survivors have been shown to significantly improve quality of life, reduce fatigue, and enhance overall well-being.

Engaging in regular physical activity may also lower the risk of recurrence for certain cancers, such as breast and colon cancer, highlighting the importance of exercise in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors. Musanti, R., Murley, B.[2018]

The ActivOnco model of care, which includes exercise prescription and rehabilitation screening, effectively improves the quality of life for cancer survivors, as demonstrated by assessments of 1635 patients and exercise prescriptions for 1066 participants from 2011 to 2015.

While exercise is beneficial, it is not a complete solution for all functional declines related to cancer and its treatment, highlighting the need for comprehensive support and resources to address the diverse rehabilitation needs of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise oncology program: translating research into a model of care. Dalzell, MA., Smirnow, N., Sateren, W., et al.[2019]

The CanWell program, a 12-week community-based exercise and education initiative for cancer survivors, led to significant improvements in health-related quality of life and physical fitness, as evidenced by enhanced performance in a 6-minute walk test and treadmill exercise protocol.

Importantly, the program was safe, with no reported increases in disease burden or exercise-related injuries among participants, highlighting its potential as a standard care practice for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Cheifetz, O., Park Dorsay, J., Hladysh, G., et al.[2015]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Triathlon training for women breast cancer survivors: feasibility and initial efficacy. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Multidisciplinary, exercise-based oncology rehabilitation programs improve patient outcomes but their effects on healthcare service-level outcomes remain uncertain: a systematic review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise in prevention and management of cancer. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Exercise in cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Mixed-method approach to informing a lifestyle intervention to improve the survivorship of patients with endometrial cancer. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of Group Dynamics-Based Exercise Versus Personal Training in Breast Cancer Survivors. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise oncology program: translating research into a model of care. [2019]

12. England pubmed.ncbi.nlm.nih.gov

CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. [2015]