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

NCT ID: NCT05869604

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-09-15

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.

Detailed Description

There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15 to 39 at diagnosis) in the US. Advances in treatment have yielded five year survival rates of >80% suggesting that the majority of AYAs will become long-term cancer survivors. While trends in survival are encouraging, the survivorship trajectories for AYAs are 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. AYA cancer survivors have more than a two-fold risk of CVD when compared to age-matched peers and are at significantly greater risk of cardiac mortality. 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. Adolescence and young adulthood are important developmental periods for the establishment of lifelong healthy behaviors, yet few AYA cancer survivors adhere to recommended guidelines for healthy eating or activity. Moreover, they report struggling to identify and maintain strategies to manage diet, improve nutrition, and increase activity. AYA survivors' efforts to engage in positive health behaviors (i.e., adhere to exercise and nutrition recommendations) necessary to manage weight may also be challenged by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress). Thus, weight gain is common, with >50% of AYA survivors classified as overweight or obese. Interventions for AYAs with obesity that aim to lower CVD risk through weight management, however, are rare and do not address symptoms that challenge healthy eating and activity despite recognition of the importance of improving health behaviors and symptom management in AYAs' transition to survivorship. The PI recently developed and evaluated a 12-session, in-person behavioral weight and symptom management intervention for breast cancer survivors with obesity and their intimate partners. Based on input from AYA cancer survivors, this intervention was adapted for AYA cancer survivors with obesity to produce an intervention responsive to AYAs' unique needs. A pilot RCT will be conducted to examine intervention feasibility and acceptability as well as patterns of change in outcomes. N=36 AYAs will be randomized to the intervention or education control arms. The protocol will be delivered via videoconferencing over 8 sessions. Assessments will be completed at baseline and post-treatment. AYAs will be weighed, have their blood pressure taken, complete a blood draw, and respond to self-report measures (e.g., symptoms, symptom interference, diet, activity). Weight and body mass index (BMI) will be assessed. Other CVD risk factors to be assessed include 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HEALTHY AYA

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 Type: EXPERIMENTAL

HEALTHY AYA

Intervention Type: BEHAVIORAL

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

Education Control

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.

Group Type: OTHER

Education Control

Intervention Type: OTHER

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

Interventions

HEALTHY AYA

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

Intervention Type: BEHAVIORAL

Education Control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline S Dorfman, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00110049

Identifier Type: -

Identifier Source: org_study_id