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Behavioural Intervention

Healthy Lifestyle Program for Young Cancer Survivors (HEALTHY-AYA Trial)

N/A

Recruiting

Led By Caroline S Dorfman, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study ways to help AYA cancer survivors manage weight, symptoms and CVD risk. Healthy eating & physical activity are key behaviors for weight loss &may protect against CVD.

Who is the study for?

This trial is for young adults aged 18-39 who had cancer and are within 2 years of completing treatment. Participants should have a BMI over 30, be healthy enough to do home-based exercise, and must understand English well enough to give informed consent.

What is being tested?

The study tests 'HEALTHY AYA', a program designed to help these survivors manage their weight and reduce cardiovascular risk through better eating habits and physical activity. It's compared with an education control group in a pilot randomized controlled trial.

What are the potential side effects?

Since the interventions involve lifestyle changes like diet modification and increased physical activity, side effects may include muscle soreness or injury from exercise, dietary changes discomforts but typically no severe side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of study recruitment

Intervention acceptability: Treatment Acceptability Questionnaire

Intervention satisfaction: SSTS-R

+3 more

Secondary study objectives

Change in Anxiety: PROMIS Anxiety Short Form

Change in Depressive Symptoms: PROMIS Depression Short Form

Change in Fatigue: PROMIS Fatigue Scale

+5 more

Other study objectives

Change in Atherosclerotic Cardiovascular Disease (ASCVD) risk

Change in HDL

Change in LDL

+6 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: HEALTHY AYAExperimental Treatment1 Intervention

Participants randomized to the intervention arm will receive an 8 session intervention providing instruction in cognitive and behavioral symptom coping strategies as well as behavioral strategies to improve diet and decrease sedentary time.

Group II: Education ControlExperimental Treatment1 Intervention

Participants randomized to the education control arm will receive information about topics of relevance to adolescent and young adult cancer survivors including sleep, cognitive problems, finances, sexual health, and return to work/school.

Do I qualify?Apply below to find out