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

NCT05869604 | Completed

• 1 other identifier: Pro00110049
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Cancer; Cardiovascular Diseases; Weight Management; Pain; Fatigue; Distress, Emotional; Physical Inactivity

Keywords

AYA Cancer Survivors; Symptom management; Health Behavior Change

Outcome Measures

Primary Outcomes (5)

• Feasibility of study recruitment

  Number of participants recruited over the course of 12 months.

  12 months

• Session attendance

  Treatment feasibility will be assessed by measuring the session attendance rate for each participant.

  Following completion of the intervention (up to 3 months)

• Participant attrition

  Participant attrition will be assessed by measuring the number of participants who drop out of the study

  Following completion of the intervention (up to 3 months)

• Intervention satisfaction: SSTS-R

  Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly disagree." The 13th item asks, "How much did the program help with the specific concern that led you to participate?" with 5 answer choices ranging from "made things a lot better" to made things a lot worse."

  Following completion of the intervention (up to 3 months)

• Open-Ended Questions About the Program

  Intervention will be evaluated using 3 open-ended questions, including the following: "1) What was the most helpful part of the program?," "2) What was the least helpful part of the program?", and "3) What suggestions do you have for us to help improve the program?"

  Following completion of the intervention (up to 3 months)

Secondary Outcomes (8)

• Change in diet and eating behavior: Three factor eating questionnaire

  Baseline, follow-up assessment (up to 3 months)

• Change in weight

  Baseline, follow-up assessment (up to 3 months)

• Change in diet: Dietary screener questionnaire

  Baseline, follow-up assessment (up to 3 months)

• Change in Physical Activity: Stanford L-Cat

  Baseline, follow-up assessment (up to 3 months)

• Change in Pain: Brief Pain Inventory (BPI)

  Baseline, follow-up assessment (up to 3 months)

Other Outcomes (9)

• Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale

  Baseline, follow-up assessment (up to 3 months)

• Change in Self-Efficacy for weight management: Weight efficacy Lifestyle questionnaire- short form

  Baseline, follow-up assessment (up to 3 months)

• Change in blood pressure (systolic and dyastolic)

  Baseline, follow-up assessment (up to 3 months)

Study Arms (2)

HEALTHY AYA

EXPERIMENTAL

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.

Behavioral: HEALTHY AYA

Education Control

OTHER

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.

Other: Education Control

Interventions

HEALTHY AYA BEHAVIORAL

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

HEALTHY AYA

Education Control OTHER

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

Education Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current pregnancy
• Non-ambulatory
• Major mental illness (i.e., schizophrenia)
• untreated /uncontrolled mental illness (i.e., bipolar disorder)
• residence \>60 miles from the research site

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases; Pain; Fatigue; Sedentary Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Caroline S Dorfman, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 22, 2023
• Study Start: December 1, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)