The Harmonized Interventions to Maintain Health Via Appropriate Risk Factor Modification and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Pilot Study

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.

Sex

All

Minimum age

18 Years

Maximum age

45 Years

Inclusion Criteria:

* Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;
* Be 18-45 years of age at the time of enrolment;
* Received cancer treatment(s) with known cardiovascular risks (e.g. anthracyclines, radiotherapy, trastuzumab, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);
* Be cancer-free at the time of enrollment.
* Diagnosed with SBHF prior to or at baseline (LVEF\<53/54%, GLS \>-18%, or diastolic dysfunction).

Exclusion Criteria:

* An absolute or relative contraindication to exercise according to the American College of Sports Medicine (ACSM) guidelines;
* Untreated physical or mental health concerns that preclude safe and effective exercise participation;
* Established CVD (excluding mildly reduced LVEF as described above);
* Be currently engaging in high-intensity exercise (\>1 high-intensity exercise session per week);
* Substantial barriers to completing study protocol (e.g. living too far away and being unable to attend testing and exercise training sessions) or unwillingness to comply with the study protocol (e.g. individual intends to start performing regular HIIT exercise regardless of randomization).