Rehabilitation for Cancer Survivors

(HIMALAYAS Trial)

Overseen By Nilina Mohabir, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Established CVD, Pregnancy, High-intensity exercise, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

336 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specialized Cardio-Oncology Rehabilitation (CORE) program can improve heart health and overall fitness in young cancer survivors with mild heart problems. The CORE program includes supervised exercise, heart risk management, and behavioral support. Researchers will compare participants to those receiving standard care, which involves typical exercise guidance for cancer survivors. The trial seeks cancer survivors diagnosed at 39 or younger, who received treatments known to affect the heart, are now cancer-free, and have mild heart issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart health strategies for young cancer survivors.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on exercise and rehabilitation, it might not require changes to your medication regimen. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Cardio-Oncology Rehabilitation (CORE) intervention is safe for pediatric, adolescent, and young adult cancer survivors?

Research has shown that cardio-oncology rehabilitation (CORE) programs are generally safe for cancer survivors with heart issues. In a study with 75 survivors, participants tolerated an 8-week CORE program well, with most completing it without major problems. Another review of similar programs found they usually do not cause serious side effects.

These programs include supervised exercise and heart health management to aid recovery. While some participants might feel tired or sore after exercising, these effects are usually mild and temporary. Overall, evidence suggests that CORE programs can be a safe option for many people seeking to improve their heart health after cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cardio-Oncology Rehabilitation (CORE) program because it offers a personalized, comprehensive approach to improving the health of cancer survivors. Unlike standard care, which typically involves basic medical monitoring, CORE combines a supervised exercise regimen with cardiovascular risk management and continuous behavioral support. This program not only addresses physical fitness through exercise but also integrates professional guidance and peer support to encourage long-term lifestyle changes, all while giving participants access to heart and activity monitoring tools for two years. This holistic strategy is designed to enhance overall well-being and tackle the unique challenges faced by cancer survivors.

What evidence suggests that the Cardio-Oncology Rehabilitation (CORE) intervention is effective for improving cardiovascular and psychosocial health in pediatric, adolescent, and young adult cancer survivors?

Research shows that Cardio-Oncology Rehabilitation (CORE), a treatment option in this trial, can assist cancer survivors with heart problems. Studies have found that exercise programs like CORE improve heart and lung function during physical activity. Participants in these programs have also managed to better control their blood pressure and cholesterol levels. They often experience an enhanced quality of life and a greater understanding of their health. The American Heart Association supports this method for improving heart health in cancer survivors. These findings suggest that CORE could benefit the heart and overall health of young cancer survivors, including children, teens, and young adults. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young cancer survivors under 39 diagnosed at the time of their cancer, now aged 18 or older. They must have had treatments with cardiovascular risks within the last 5 years and be free of cancer at enrollment. Participants should have mild heart dysfunction but cannot join if they don't meet specific heart health criteria.

Inclusion Criteria

I've had cancer treatments that could affect my heart in the last 5 years.

I was diagnosed with cancer at or before the age of 39.

I have been diagnosed with a specific heart condition affecting its function and structure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-month supervised CORE intervention, including moderate to high-intensity aerobic exercise training, CVD risk factor modification, and enhanced online behavioral support

6 months

Weekly in-person and virtual/home-based sessions

Follow-up

Participants are monitored for cardiorespiratory fitness, cardiac function, CVD risk factors, and patient-reported outcomes

18 months

Regular follow-up assessments

Long-term Follow-up

Ongoing behavioral support and monitoring of physical activity and health outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Cardio-oncology Rehabilitation (CORE)
• Exercise Guidelines for Cancer Survivors (ExGL)
• PAI Group (PAI)

Trial Overview The HIMALAYAS study tests a Cardio-Oncology Rehabilitation (CORE) program against standard care in young adult cancer survivors with mild heart issues. CORE includes exercise, behavioral support, and managing heart disease risk factors over six months to improve fitness and psychosocial health.

How Is the Trial Designed?

Group I: Cardio-Oncology Rehabilitation (CORE) Experimental Treatment 1 Intervention

Participants in the CORE group will have 1. A personalized, supervised exercise program ((in-person at intuition and virtual/ homebased exercises) 2. CV risk factor management, 3. behavioural support for the first 6 months. The behavioural support will continue for CORE participants from months 7-24. Behavioural support includes professionally guided and peer-enhanced exercise behavioural support based on behaviour change stage theories. CORE participants will be provided a wrist-worn heart and physical activity monitor to use throughout the 24-month observation period.

Group II: Standard of Care (CON) Active Control 1 Intervention

Participants in the CON group will receive standard medical care and physical activity will be monitored by a wrist-worn activity tracker for 2 years.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials

26

Recruited

14,200+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Vancouver General Hospital

Collaborator

Trials

42

Recruited

19,700+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Published Research Related to This Trial

As the number of cancer survivors increases, so does the risk of cardiovascular disease (CVD) among them, highlighting the need for integrated care in cancer treatment.

Cardio-oncology rehabilitation (CORE) is a new approach designed to reduce CVD risk and enhance fitness in cancer survivors through tailored exercise and cardiac rehabilitation, addressing the emerging issue of cancer treatment-related cardiovascular disease (CTRCD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. Sase, K., Kida, K., Furukawa, Y.[2021]

The rise in cancer survival rates has led to an increase in patients facing both cancer and cardiovascular diseases, highlighting the need for integrated care in cardio-oncology to manage shared risk factors and mitigate the cardiotoxic effects of cancer treatments.

The Cardio-Oncology REhabilitation (CORE) program is an exercise-based intervention designed to improve cardiovascular health in cancer patients, offering benefits such as enhanced cardiorespiratory fitness, better quality of life, and psychological support, while also addressing barriers to its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The core components of cardio-oncology rehabilitation. Venturini, E., Gilchrist, S., Corsi, E., et al.[2022]

A 12-week home-based cardio-oncology rehabilitation (CORE) program using telerehabilitation was found to be safe and feasible for 11 hematological cancer survivors, with 80% adherence to the exercise sessions.

Participants showed a significant improvement in cardiorespiratory fitness, with an increase of 2.6 ml/kg/min and peak workload, indicating that this intervention can effectively enhance fitness levels in cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. Filakova, K., Janikova, A., Felsoci, M., et al.[2023]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

Cardiac rehabilitation (CR) for cancer survivors shows low-to-moderate quality in reporting and moderate-to-high risk of bias, which affects the reliability of the findings and their application in clinical practice.

Despite the quality concerns, survivors who completed CR demonstrated improved cardiorespiratory fitness and reduced fatigue compared to those who did not participate in CR, suggesting potential benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. Fakhraei, R., Peck BKin, SS., Abdel-Qadir, H., et al.[2022]

Cancer survivors often face impairments from their disease and treatment that can be improved through rehabilitation, highlighting the need for specialized programs.

Existing community-based cardiac rehabilitation (CR) programs can be adapted to create effective oncology rehabilitation services, requiring only minor adjustments, and preliminary evidence shows that these programs can enhance both psychological and physiological well-being in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based oncology rehabilitation: leveraging the cardiac rehabilitation model. Dittus, KL., Lakoski, SG., Savage, PD., et al.[2018]

Cancer patients, especially those with early-stage disease, face a higher risk of cardiovascular disease due to both cancer treatments and lifestyle factors, highlighting the need for effective risk mitigation strategies.

The American Heart Association advocates for a multimodal approach, specifically cardiac rehabilitation, to support cancer patients by providing structured exercise and addressing unique cardiac risks associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Gilchrist, SC., Barac, A., Ades, PA., et al.[2020]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2810101

Cardio-Oncology Rehabilitation for Cancer Survivors With ... Recent data from a large noncontrolled study showed that exercise-based CR was associated with improve cardiorespiratory fitness and survival in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38788778/

Cost-effectiveness analysis of a cardio-oncology ... A cardio-oncology rehabilitation model among cancer survivors showed superior results comparing to a community-based exercise intervention.

3. academic.oup.com academic.oup.com/eurheartj/article/46/29/2847/8046087

Cardio-oncology rehabilitation and exercise: evidence ... The intervention caused significant improvements in peak oxygen uptake, cardiovascular risk factor control, quality of life, and health literacy ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000679

Cardio-Oncology Rehabilitation to Manage Cardiovascular ... Collectively, current investigations indicate that CR models are feasible and can improve CRF, muscular strength, and quality of life in cancer ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X23017397

Cardio-oncology and Cancer Rehabilitation The American Heart Association endorses a multimodal cardiac rehabilitation (CR)-based approach to improve cardiovascular outcomes in cancer survivors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314747/

Cardio-oncology rehabilitation and exercise - PubMed Central The aim of this whitepaper is to review the current state of the literature on the effects of cardio-oncology rehabilitation and exercise (CORE) programmes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9936479/

Adherence, safety, and satisfaction of a cardio-oncology ... To assess safety, satisfaction, and overall adherence of a center-based cardiac rehabilitation (CBCR) program for cancer survivors at increased cardiovascular ...

8. jacc.org jacc.org/doi/10.1016/j.jaccao.2022.03.003

Research Quality and Impact of Cardiac Rehabilitation in ... The aim of this study was to evaluate the quality of reporting and evidence from CR-based intervention studies in oncology and to explore associations