← Back to Search

Behavioural Intervention

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

N/A

Recruiting

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

HEALTHY-AYA Trial 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.Check my eligibility

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.See study design

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.

HEALTHY-AYA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of study recruitment

Intervention acceptability: Treatment Acceptability Questionnaire

Intervention satisfaction: SSTS-R

+3 more

Secondary outcome measures

Change in Anxiety: PROMIS Anxiety Short Form

Change in Depressive Symptoms: PROMIS Depression Short Form

Change in Fatigue: PROMIS Fatigue Scale

+5 more

Other outcome measures

Change in Atherosclerotic Cardiovascular Disease (ASCVD) risk

Change in HDL

Change in LDL

+6 more

HEALTHY-AYA 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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,606 Total Patients Enrolled

1 Trials studying Sedentary Lifestyle

84 Patients Enrolled for Sedentary Lifestyle

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals of an underage age qualify for this research project?

"This medical trial is strictly for individuals between 18 and 39 years old as per the set eligibility requirements."

Answered by AI

What is the goal of this experiment?

"This clinical trial is primarily assessing the efficacy of Open-Ended Questions About the Program over a 3 month period. Secondary endpoints include Change in diet (as measured by the Dietary Screener Questionnaire), Change in Physical Activity (utilising Stanford's L-Cat) and Change in Pain, which will be gauged using Brief Pain Inventory (BPI)."

Answered by AI

What is the total population of individuals involved in this investigation?

"Affirmative. Information available on clinicaltrials.gov suggests that this medical study is actively recruiting patients, with the initial posting occurring on November 15th 2023 and the most recent update taking place on 11/10/2023. 36 individuals are sought after from a single site for enrolment in the trial."

Answered by AI

Is enrollment open for this clinical investigation?

"The clinical trial is presently seeking participants, as confirmed by the most recent update on November 10th 2023. This research was first published on November 15th 2023."

Answered by AI

What criteria must a prospective participant meet to enroll in this trial?

"The trial is enrolling 36 individuals between ages 18 and 39 who lead a sedentary lifestyle. To be considered for admission, candidates must possess the following characteristics: have experienced cancer in their past, been diagnosed within 2 years of completing treatments, BMI higher than 30, capable of safely taking part in home-based physical activity sessions, able to provide informed consent documents, and proficiently understand English language."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors

2023. "Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05869604.

All > Weight Loss High Point