MedTrace Logo

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

NCT05869604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-03-31

No results posted yet for this study

Summary

There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15 to 39 at diagnosis) in the US. Survivorship for AYAs is often complicated by long-term and late-effects. Cardiovascular disease (CVD), in particular, is a leading cause of death for cancer survivors and is a growing public health concern for survivors diagnosed as AYAs. Risk of CVD may be associated with treatment exposures and may be potentiated by weight gain and poor health behaviors. Healthy eating and physical activity are key behaviors for weight loss and maintenance and may be protective against CVD risk, yet few AYA cancer survivors adhere to guidelines for healthy eating or activity. AYA survivors' abilities to engage in health behaviors (i.e., healthy eating, physical activity) necessary to manage weight may also be challenged by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress). Thus, weight gain is common. Using input from AYA cancer survivors, the investigators have adapted a behavioral weight and symptom management protocol for AYA cancer survivors with obesity to create an intervention that is responsive to AYAs' unique needs. A pilot randomized controlled trial will be conducted to examine intervention feasibility and acceptability and to examine patterns of change in outcomes including weight, body mass index, symptoms (e.g., pain, fatigue, distress) as well as other CVD risk factors, including blood pressure, cholesterol (total, HDL, LDL), HbA1c, and atherosclerotic cardiovascular disease (ASCVD) risk score.

Conditions

Interventions

BEHAVIORAL

HEALTHY AYA

8-session health lifestyle behavior intervention combining behavioral symptom management strategies with strategies to improve diet and increase physical activity.

OTHER

Education Control

Participants will receive paper materials on topics of relevance to adolescent and young adult cancer survivors.

Sponsors & Collaborators

Principal Investigators

  • Caroline S Dorfman, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-09-15
Completion
2025-09-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869604 on ClinicalTrials.gov