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Rehabilitation for Cancer Survivors (HIMALAYAS Trial)

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received cancer treatment(s) with known cardiovascular risks (e.g. anthracyclines, radiotherapy, trastuzumab, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors) in the previous 5 years;

Be an AYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study initiation to end of 66-month study period (primary and secondary rcts)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of a Cardio-Oncology Rehabilitation (CORE) program on the cardiovascular and psychosocial health of pediatric, adolescent, and young adult cancer survivors (PAYA-CS

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include muscle soreness, fatigue from exercise programs in CORE intervention; however, these are generally well-tolerated and beneficial for long-term cardiovascular health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I am 18 years old or older.

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I am currently cancer-free.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study initiation to end of 66-month study period (primary and secondary rcts)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study initiation to end of 66-month study period (primary and secondary rcts)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study initiation to end of 66-month study period (primary and secondary rcts) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiorespiratory fitness

Secondary study objectives

Anaerobic threshold

Anxiety

Apolipoprotein B

+27 more

Other study objectives

Behavioural Compliance

Energy expenditure during HIIT

Exercise Adherence

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cardio-Oncology Rehabilitation (CORE)Experimental Treatment1 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 Control1 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.

0 / 5Eligibility criteria met