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NCT05869604Completed

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

Improving Cardiovascular Disease Risk Factors in Survivors of Adolescent and Young Adult Cancer With Obesity: Adaptation and Pilot Testing of a Behavioral Weight and Symptom Management Intervention

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
38 (actual)
First submitted
10 May 2023
Start date
1 Dec 2023
Primary completion date
15 Sept 2025
Lead sponsor
Duke University
Diseases
Obesity
NCT number
NCT05869604

What you commit to

  • Study type: Interventional
  • Participants enrolled: 38
  • From 1 Dec 2023 to the primary completion date, 15 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Major mental illness (i.e., schizophrenia)
  • untreated /uncontrolled mental illness (i.e., bipolar disorder)

Other

  • Current pregnancy
  • Non-ambulatory
  • residence \>60 miles from the research site

Who the study is looking for

  • History of cancer
  • Diagnosed with cancer between the ages of 18 and 39
  • Within 5 years of completing cancer treatments
  • BMI \>30
  • Healthy enough to participate in home-based physical activity
  • Able to speak and read English
  • Able to provide informed consent

Age in the registry: 18 years to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.