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

N/A

Waitlist Available

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

Be cancer-free at the time of enrollment

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

Must not have

Established CVD (excluding mildly reduced LVEF as described above)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study recruitment, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of exercise on the heart health and overall well-being of young cancer survivors at risk of heart problems. The researchers want to see if a structured exercise program can improve cardiovascular

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this intervention involves exercise and support without medical or drug treatments, side effects may include typical exercise-related issues like muscle soreness or fatigue. The trial will monitor for any adverse reactions related to the program.

Eligibility Criteria

Inclusion Criteria

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

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I am currently free of cancer.

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

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I am 18 years old or older.

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I have been diagnosed with heart failure based on specific heart function tests.

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My heart's pumping ability is below normal or I have heart muscle issues.

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I am currently free of cancer.

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

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart disease, but not just a slightly weak heart pump.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study recruitment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study recruitment, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study recruitment, up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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

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

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

Secondary study objectives

Attrition (feasibility target <=15% loss to follow-up)

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

Behavioural compliance (feasibility target >=70% of prescribed)

+13 more

Other study objectives

Anxiety

Cardiac function

Depression

+12 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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Support

2011

N/A

~580

0 / 9Eligibility criteria met