Exercise Program for Young Cancer Survivors
(HIMALAYAS-P Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

Cardiovascular disease (CVD) is a major contributor to morbidity and mortality in pediatric, adolescent and young adult (AYA) cancer survivors (hereafter referred to as PAYA-CS). Exercise is a cornerstone of CVD prevention and treatment; yet, exercise has not been adopted as a standard of care in PAYA-CS at high CVD risk. The HIMALAYAS trial is designed to evaluate the feasibility and preliminary impact of an exercise-based CR on cardiovascular (CV) and psychosocial health, as well as CVD risk, in PAYA-CS with mild heart dysfunction (stage B heart failure (SBHF)). The primary objective of the HIMALAYAS pilot study is to assess the feasibility of a two-phase randomized controlled trial designed to evaluate impact of a 'CR-like' cardio-oncology rehabilitation (CORE) intervention on CV, psychosocial, and behavioural outcomes at 6 and 24 months, compared to behavioural support only (Support) in PAYA-CS. Screened PAYA-CS without SBHF and those with SBHF who do not participate in the RCT will be enrolled in a passive behavioural support (Support) group. The primary outcome is study feasibility, defined according to three primary criteria (i.e., participant recruitment, safety, and adherence). Secondary outcomes include additional feasibility metrics (e.g., intervention safety and tolerability) and exploratory efficacy outcomes including peak cardiorespiratory fitness (VO2peak), cardiac function (e.g., global longitudinal strain (GLS)), CVD risk factor control (e.g. insulin resistance), and patient-reported outcomes (e.g. anxiety). Our central hypothesis is that the conduct of a larger RCT comparing the impact of CORE versus non-intervention control will be feasible indicated by the achievement of our primary feasibility criteria. Our exploratory hypothesis is that we will generate preliminary evidence that CORE can improve VO2peak, cardiac function, CVD risk factor, and patient-reported outcomes over 6- and 24-month timepoints, relative to control.

Research Team

Eligibility Criteria

This trial is for young cancer survivors under 39 years old at diagnosis, now aged 18+, who've had treatments with heart risks in the past year and are currently cancer-free. They must have mild heart dysfunction but can't join if they don't meet these specific health criteria.

Inclusion Criteria

I have received cancer treatments that could affect my heart.

I am currently free of cancer.

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

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Exclusion Criteria

Be currently engaging in high-intensity exercise (>1 high-intensity exercise session per week)

I do not have untreated health issues that stop me from safely exercising.

An absolute or relative contraindication to exercise according to the American College of Sports Medicine (ACSM) guidelines

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Treatment Details

Interventions

Cardio-oncology Rehabilitation (CORE) (Behavioural Intervention)
Passive Behavioural Support (Behavioural Intervention)
Support (Behavioural Intervention)

Trial OverviewThe HIMALAYAS study tests an exercise-based cardio-oncology rehab (CORE) to see its effects on heart and psychosocial health versus just getting behavioral support. It's a pilot study to check if a larger trial would be workable, focusing on safety and how well participants stick with it.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: SupportExperimental Treatment1 Intervention

The Support group will receive the behavioural support only. The timing and nature of all education, information provided to Support participants will be identical to what is provided to CORE participants. All Support participants will receive the same wrist-worn HR monitor and PA tracker as the CORE participants and will be given the challenge of meeting and maintaining the updated PA guidelines for cancer survivors (i.e., 90 to 150 minutes of moderate to vigorous intensity PA per week).

Group II: Cario-Oncology Rehabilitation (CORE)Experimental Treatment1 Intervention

CORE consists of exercise therapy, CVD risk factor management, and behavioural support for 3 months. Exercise therapy: Staff will prescribe and deliver a standardized, yet individually tailored (based on CPET results), aerobic exercise programs consisting of two days of supervised, facility- and home-based high-intensity interval training (HIIT) and one day of supervised home-based moderate-intensity continuous training (MICT) per week. Exercise HRs and durations will be monitored using an accurate commercially available wrist-worn HR monitor and PA tracker. CVD risk factor management: CVD risk factors will be assessed and treated according to Canadian guidelines. Behavioural support: All participants will receive a planned sequence of educational and instructional material via email and ongoing PAYA-CS tailored education and peer support during the follow-up period using a peer support online system.