Exercise and Education Program for Cancer

(IMPACT Trial)

Recruiting at 2 trial locations

Overseen By Jenna Smith-Turchyn, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Disqualifiers: Chronic condition, Cognitive impairment, Injury, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

129 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new exercise and education program for individuals undergoing cancer treatment. Participants will be divided into three groups: one will receive supervised exercise and self-management education (Exercise and Self-Management), another will participate in virtual self-management sessions (Self-Management Only), and the last group will receive their usual care. The goal is to identify ways to help cancer patients remain active and manage their health more effectively during treatment. The trial seeks adults diagnosed with cancer who are currently receiving treatment and have been cleared to exercise by their care team. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to potentially beneficial advancements in cancer care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on exercise and education for cancer patients during treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining exercise with self-management education is safe for people with cancer. These programs can help reduce treatment side effects. For example, exercise can decrease fatigue and enhance overall quality of life without causing serious side effects. Additionally, supervised exercise programs are generally safe, with few reports of negative effects.

Evidence for the self-management-only approach is also encouraging. Reviews of digital self-management tools have found them helpful for cancer patients, improving quality of life without major safety concerns.

Overall, both the combined exercise and self-management approach and the self-management-only approach are safe. These strategies are well-tolerated and can be an important part of cancer care without adding significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise and Education Program for Cancer because it explores how integrating exercise with self-management education can enhance care for cancer patients. Unlike traditional treatments that often focus solely on medication or surgery, this approach emphasizes empowering patients with skills to manage their health actively. The unique combination of physical activity and self-management strategies could improve not just physical health but also mental well-being and overall quality of life. This trial aims to uncover whether this holistic approach can provide benefits beyond what usual care offers, potentially leading to more comprehensive support for cancer patients.

What evidence suggests that this trial's exercise and education strategies could be effective for cancer patients?

Research shows that staying active can significantly benefit individuals undergoing cancer treatment. In this trial, participants in the "Exercise & Self-Management" arm will combine exercise with self-care management. Studies have found that this combination can reduce treatment side effects, decrease fatigue, and improve overall quality of life. One study found that participants in these programs reported higher satisfaction and better adherence to routines, leading to improved outcomes.

For participants in the "Self-Management Only" arm, research suggests that digital tools can be beneficial. These tools assist with decision-making and goal-setting, which are crucial for managing health during cancer treatment. Overall, both exercise and self-management strategies have shown promising results in supporting the well-being of cancer patients. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Ontario who are currently undergoing chemotherapy, radiation, or hormonal therapy for cancer. They must be living in the community, speak English, and have clearance from their oncologist to do moderate exercise.

Inclusion Criteria

I live in my own home or with family.

I am over 18 years old.

My oncologist approves of me doing moderate exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into three groups: Exercise & Self-Management, Self-Management Only, and Usual Care. Group 1 receives eight sessions of supervised, in-person exercise and self-management education, plus 4 booster sessions by phone. Group 2 receives eight virtual self-management education sessions, plus 4 booster sessions by phone. Group 3 receives usual care.

8 weeks

8 visits (in-person or virtual), 4 booster sessions (phone)

Follow-up

Participants are monitored for physical activity levels and other health outcomes using questionnaires and tests.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Self-Management
• Self-Management Only

Trial Overview The trial tests a new strategy combining supervised exercise sessions with self-management education against self-management only or usual care without intervention. Participants will be randomly assigned to one of these three groups.

How Is the Trial Designed?

Group I: Self-Management Only Experimental Treatment 1 Intervention

Group II: Exercise & Self-Management Experimental Treatment 2 Interventions

Group III: Usual Care Active Control 1 Intervention

Exercise and Self-Management is already approved in Canada for the following indications:

Approved in Canada as Exercise and Self-Management for:

• Supportive care during cancer treatment
• Improvement of physical and psychosocial well-being in cancer survivors

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Niagara Health System

Collaborator

Trials

9

Recruited

2,800+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Published Research Related to This Trial

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

A study of 350 cancer patients receiving physical therapist-led exercise counseling showed significant reductions in global distress and fatigue, indicating that exercise counseling can effectively improve symptoms related to cancer treatment.

Patients reported notable improvements in overall health and well-being after counseling, suggesting that exercise may play a crucial role in enhancing quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapist-Led Exercise Assessment and Counseling in Integrative Cancer Care: Effects on Patient Self-reported Symptoms and Quality of Life. Lopez, G., Eddy, C., Liu, W., et al.[2023]

This study will assess the effectiveness of a 12-week home-based exercise and self-management program for lung cancer patients post-surgery, comparing it to usual care in a randomized controlled trial with 112 participants.

The primary outcome is improvement in physical function, measured by the EORTC QLQ c30 questionnaire, with secondary outcomes including health-related quality of life and exercise capacity, evaluated over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): protocol for a randomised controlled trial. Granger, CL., Edbrooke, L., Antippa, P., et al.[2022]

A randomized trial involving 187 patients with newly diagnosed multiple myeloma found that a home-based individualized exercise program (HBIEP) did not significantly reduce fatigue, improve sleep, or enhance aerobic performance compared to usual care over a 15-week period.

Despite the minimal impact on fatigue and performance, the study suggests that exercise is safe for patients undergoing treatment for multiple myeloma and may provide physiological benefits, particularly in alleviating anemia when combined with epoetin alfa therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. Coleman, EA., Goodwin, JA., Kennedy, R., et al.[2021]

A study involving 72 cancer patients showed that a combined program of physical exercise, education, and emotional support significantly reduced illness stress and improved health promotion lifestyle after 10 weeks, particularly in areas like social relationships and stress management.

While the program effectively lowered stress and enhanced lifestyle, it did not significantly impact hope and resilience, indicating a need for further research to address these emotional aspects in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Tripod Approach for Cancer Patients on Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience. Sung, KM., Yu, M., Kang, YS., et al.[2021]

In a systematic review of 129 trials with 12,044 participants, exercise during systemic cancer treatment was associated with a higher risk of serious adverse events, thromboses, and fractures compared to control groups.

Despite these risks, exercise also correlated with a lower incidence of fever and a higher relative dose intensity of systemic treatment, indicating potential benefits, but the overall certainty of evidence regarding the harms and benefits of exercise in this context is very low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms of exercise training in patients with cancer undergoing systemic treatment: a systematic review and meta-analysis of published and unpublished controlled trials. Thomsen, SN., Lahart, IM., Thomsen, LM., et al.[2023]

This study aims to evaluate the effectiveness of an exercise program combined with self-management strategies for women with breast cancer undergoing chemotherapy, focusing on improving physical activity levels, quality of life, and overall health outcomes over 12 months.

Participants will be randomly assigned to one of three groups: institution-based exercise plus self-management, self-management alone, or usual care, with outcomes measured at multiple time points to assess the impact of the interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel strategy to implement exercise evidence into clinical practice in breast cancer care: protocol for the NEXT-BRCA randomised controlled trial. Smith-Turchyn, J., Mukherjee, S., Richardson, J., et al.[2022]

Exercise prehabilitation is crucial for preparing cancer patients for treatments like surgery, with evidence supporting its role in improving fitness and strength, particularly through supervised moderate-intensity aerobic and resistance exercises.

Multimodal prehabilitation programs that include exercise, nutritional support, and psychological interventions are becoming standard practice, enhancing patient outcomes and adherence to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Exercise Before Cancer Treatment. Denehy, L., Edbrooke, L.[2022]

A survey of 420 metastatic breast cancer patients revealed that while 68% felt skilled enough for aerobic exercise, only 35% felt confident in resistance exercise, indicating a gap in exercise engagement.

Barriers such as lack of access to programs, fatigue, and weakness hinder participation, but personalized advice and positive past experiences can encourage regular exercise, highlighting the need for tailored support and consideration of insurance reimbursement in program implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of patients with metastatic breast cancer on physical exercise programs: results from a survey in five European countries. Sweegers, MG., Depenbusch, J., Kampshoff, CS., et al.[2023]

Exercise and physical activity are crucial for cancer survivors, as they help combat reduced physical function and improve overall health during and after treatment.

Combining aerobic and resistance training is especially beneficial for patients experiencing cachexia, and emerging evidence suggests that nutritional support alongside exercise can enhance these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training in cancer patients. Maddocks, M.[2021]

Citations

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Physical Activity and Cancer Care—A Review - PMC The findings from these studies show that physical activity decreases the severity of side effects of cancer treatment, reduces fatigue, improves quality of ...

2. nature.com nature.com/articles/s41598-025-11660-0

Implementing exercise and self-management for women ... The results of this RCT study suggest that combined exercise and SM has increased benefits for physical activity level, quality of life, health ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9770433/

Self-managed physical activity in cancer survivors for the ... Exercise is more effective than health education in reducing fatigue in fatigued cancer survivors. Support Care Cancer. 2020;28: 4953–4962 ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827190

Home-Based Exercise and Self-Management After Lung ... The findings suggest that although a home-based exercise and self-management program did not improve physical function, it improves some important clinical ...

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

Interim results and program satisfaction of the EXCEL study Overall, satisfaction with the EXCEL study was positive, possibly contributing to the high adherence rate of 80.1% and reported benefits. Participants not only ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04109274

Study Details | NCT04109274 | Implementing Exercise Into ... Women will be divided into three groups. The first group will include 8 sessions of exercise and self-management education during their chemotherapy treatment.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11956335/

Implementing physical activity for individuals with cancer ... A novel implementation strategy using PA and self-management versus usual care during cancer treatment.

8. withpower.com withpower.com/trial/phase-2-malignancies-2-2024-279e6

Exercise and Education Program for Cancer (IMPACT Trial) Research shows that supervised exercise programs for cancer patients, including children, are generally safe with very few adverse events (unwanted effects).