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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to offer exercise programs specifically for cancer survivors in rural or remote areas, helping them become long-term exercisers. Exercise provides proven benefits for cancer survivors, but those in remote locations often lack tailored programs. Participants will attend group exercise classes twice a week for 12 weeks. Ideal candidates have received a cancer diagnosis, are either undergoing treatment or have completed treatment within the last five years, and can engage in mild physical activities. As an unphased trial, this study offers a unique opportunity for participants to access specialized exercise programs that can significantly enhance their recovery and quality of life.

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 prior data suggests that this exercise program is safe for cancer survivors?

Research has shown that exercise programs can safely help cancer survivors improve their health. The EXCEL study, an exercise program for cancer survivors, showed promising results. Participants joined group exercise classes that included heart-healthy, strength-building, balance, and flexibility exercises.

Results from the EXCEL study indicated that participants tolerated these exercises well, with no major negative side effects reported. The program is designed to be safe and supportive, particularly for those in rural or remote areas who might not have easy access to exercise options.

In summary, group exercise classes, like those in the EXCEL study, are generally safe for cancer survivors and help improve overall well-being without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the group exercise classes for cancer survivors because they offer a holistic approach to recovery that goes beyond traditional medical treatments like chemotherapy, radiation, or surgery. Unlike these standard treatments, which primarily target the cancer itself, exercise focuses on improving overall well-being, boosting mood, reducing fatigue, and enhancing physical function. This program's unique aspect is its emphasis on community support through group classes, which can increase motivation and foster a sense of belonging among participants. By incorporating regular exercise into recovery, this approach aims to improve both physical and mental health, offering survivors a more comprehensive path to wellness.

What evidence suggests that group exercise classes are effective for cancer survivors?

Research has shown that group exercise classes can greatly aid people recovering from cancer. In this trial, all participants will attend group exercise classes twice a week for 12 weeks. Studies have found that exercise effectively supports cancer recovery. Participants in exercise programs often report feeling fitter and experiencing a better quality of life. One study found that 81.4% of participants completed a 12-week exercise program, indicating strong interest and commitment among cancer survivors. This suggests that regular exercise can significantly enhance overall well-being for those recovering from cancer. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9915392/

First-Year Implementation of the EXercise for Cancer to ... Of the 290 enrolled participants, 236 completed the 12-week exercise oncology program (retention rate = 81.4%). Reasons for study drop-out included “no longer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04478851

EXCEL: Exercise for Cancer to Enhance Living Well The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772696724000036

Interim results and program satisfaction of the EXCEL study EXCEL's group-based exercise program with behaviour change support, delivered in an online supervised setting to individuals living with cancer, may improve ...

4. kinesiology.ucalgary.ca kinesiology.ucalgary.ca/labs/health-and-wellness/research/research-studies/exercise-cancer-enhance-living-well-excel

Exercise for Cancer to Enhance Living Well (EXCEL) The EXCEL Study provides a free 8-12-week exercise program, for people undergoing or recovering from cancer treatment, living in rural and remote regions ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/12/e063953

Implementing an exercise oncology model to reach rural ... Exercise is an evidence-based supportive cancer care resource that is both safe and effective at alleviating symptom burden, improving fitness, QOL3, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11941420/

Exploring Healthcare Provider Experiences with the EXCEL ... EXCEL is an exercise intervention designed to address health disparities in access to exercise oncology resources for rural/remote individuals ...