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

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise and Self-Management, Physical Activity and Education, Exercise and Self-Management Education, Self-Management Only, Self-Management Only, Virtual Self-Management Education for cancer patients?

Research shows that exercise and self-management programs can help cancer patients by improving physical function, quality of life, and reducing treatment-related side effects. Studies have found that these programs are beneficial for breast and lung cancer patients, suggesting they may be effective for other cancer types as well. ^{1 2 3 4 5}

Is the Exercise and Education Program for Cancer safe for participants?

Research shows that supervised exercise programs for cancer patients, including children, are generally safe with very few adverse events (unwanted effects). Most common minor issues include muscle soreness and mild circulatory problems, but serious problems are rare. ^{1 6 7 8 9}

How is the Exercise and Education Program for Cancer treatment different from other treatments for cancer?

This treatment is unique because it combines exercise with self-management education, providing both physical and emotional support to help cancer patients manage their health at home. Unlike traditional treatments that focus solely on medical interventions, this program emphasizes the importance of physical activity and education to improve patients' overall well-being and resilience. ^{1 4 5 9 10}

What is the purpose of this trial?

More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice. What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment. What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention). In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment. Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario.

Eligibility Criteria

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.

I am currently receiving treatment to reduce my cancer risk before or after surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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]

References

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

The Effects of a Tripod Approach for Cancer Patients on Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience. [2021]

2. England 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. [2022]

3. United States 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. [2023]

4. England 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. [2022]

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

Perspectives of patients with metastatic breast cancer on physical exercise programs: results from a survey in five European countries. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

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

Effects of exercise on fatigue, sleep, and performance: a randomized trial. [2021]

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

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

The Role of Exercise Before Cancer Treatment. [2022]