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

NCT04598646 | Completed

• 1 other identifier: 21-5391.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Cardiotoxicity; Cancer

Keywords

Adolescents and Young Adults; Exercise Therapy; Behavioral and Peer Support; Cardiac Rehabilitation; Cancer Survivor

Outcome Measures

Primary Outcomes (3)

• Patient Access and Recruitment (feasibility target: >50% of eligible participants)

  Defined as the percent of consenting patients based on the total number of otherwise eligible participants (OEP; patients meeting all eligibility criteria) approached

  Throughout study recruitment, up to 2 years

• Testing- and intervention-related serious adverse events (feasibility target: none)

  Defined as the number and frequency of testing- and intervention-related serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events

  Initiation through end of study recruitment 12 months

• Patient exercise adherence (feasibility target: >=70% of prescribed)

  Defined as relative dose intensity as the percent of total dose of exercise performed relative to the total planned dose prescribed and quantified according to metabolic equivalents

  Initiation throughout end of CORE intervention at a maximum of 6 months post-randomization

Secondary Outcomes (16)

• Patient identification rate (feasibility target: >=50% of OEP)

  Initiation through end of study recruitment 12 months

• Baseline assessment rate (feasibility target >=90% of consenting participants)

  Initiation through end of study recruitment 12 months

• Testing- and intervention-related non-serious adverse events (feasibility target <=20% of consenting participants)

  Initiation through end of study recruitment 12 months

• Testing performance (feasibility target >=95% of consenting participants)

  Initiation through end of study recruitment 12 months

• Testing modality adaptation (descriptive)

  Initiation throughout end of CORE intervention at a maximum of 6 months post-randomization

Other Outcomes (22)

• VO2peak

  baseline, 6-, 12- and 24-month follow ups

• Cardiac function

  baseline, 6-, 12- and 24-month follow ups

• Cardiac function

  baseline, 6-, 12- and 24-month follow ups

Study Arms (2)

Cario-Oncology Rehabilitation (CORE)

EXPERIMENTAL

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.

Behavioral: Cardio-oncology Rehabilitation (CORE)

Support

EXPERIMENTAL

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).

Behavioral: Support

Interventions

Cardio-oncology Rehabilitation (CORE) BEHAVIORAL

Exercise therapy, CVD risk factor management for the first 6 months (as per current standards in CR models) and behavioural support for the entire 2-year intervention period

Cario-Oncology Rehabilitation (CORE)

Support BEHAVIORAL

Behavioural support via professionals and peer support and recommended physical activity guidelines for cancer survivors, to encourage physical activity.

Support

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

MeSH Terms

Conditions

Heart Failure; Cardiotoxicity; Neoplasms; Behavior

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: October 22, 2020
• Study Start: April 1, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CA (1)