Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors (HEALTHY-AYA)

March 26, 2026 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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 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
Participants will receive paper materials on topics of relevance to adolescent and young adult cancer survivors.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of study recruitment
Time Frame: 12 months
Number of participants recruited over the course of 12 months.
12 months
Session attendance
Time Frame: Following completion of the intervention (up to 3 months)
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
Time Frame: Following completion of the intervention (up to 3 months)
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
Time Frame: Following completion of the intervention (up to 3 months)
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
Time Frame: Following completion of the intervention (up to 3 months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in diet and eating behavior: Three factor eating questionnaire
Time Frame: Baseline, follow-up assessment (up to 3 months)
Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.
Baseline, follow-up assessment (up to 3 months)
Change in weight
Time Frame: Baseline, follow-up assessment (up to 3 months)
Participants will be weighed at each assessment.
Baseline, follow-up assessment (up to 3 months)
Change in diet: Dietary screener questionnaire
Time Frame: Baseline, follow-up assessment (up to 3 months)
The Dietary Screener Questionnaire is a 25-item measure asking participants to rate on the frequency of eating/drinking certain foods in the last week.
Baseline, follow-up assessment (up to 3 months)
Change in Physical Activity: Stanford L-Cat
Time Frame: Baseline, follow-up assessment (up to 3 months)
The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.
Baseline, follow-up assessment (up to 3 months)
Change in Pain: Brief Pain Inventory (BPI)
Time Frame: Baseline, follow-up assessment (up to 3 months)
The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.
Baseline, follow-up assessment (up to 3 months)
Change in Fatigue: PROMIS Fatigue Scale
Time Frame: Baseline, follow-up assessment (up to 3 months)
The Promis Fatigue Scale is a 8-item self-report measure of fatigue in the last week. Participants are asked to respond to items (e.g., "I felt fatigued", "I have troubled starting things because I am tired") using scales ranging from 1 to 5.
Baseline, follow-up assessment (up to 3 months)
Change in Depressive Symptoms: PROMIS Depression Short Form
Time Frame: Baseline, follow-up assessment (up to 3 months)
Depressive Symptoms will be assessed using the PROMIS Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always."
Baseline, follow-up assessment (up to 3 months)
Change in Anxiety: PROMIS Anxiety Short Form
Time Frame: Baseline, follow-up assessment (up to 3 months)
Symptoms of Anxiety will be assessed using the PROMIS Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always".
Baseline, follow-up assessment (up to 3 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale
Time Frame: Baseline, follow-up assessment (up to 3 months)
The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 "not at all confident" to 10 "totally confident."
Baseline, follow-up assessment (up to 3 months)
Change in Self-Efficacy for weight management: Weight efficacy Lifestyle questionnaire- short form
Time Frame: Baseline, follow-up assessment (up to 3 months)
The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= "not at all confident" to 10= "very confident."
Baseline, follow-up assessment (up to 3 months)
Change in blood pressure (systolic and dyastolic)
Time Frame: Baseline, follow-up assessment (up to 3 months)
Both systolic and dyastolic blood pressure will be assessed at the baseline and follow-up assessment.
Baseline, follow-up assessment (up to 3 months)
Change in total cholesterol
Time Frame: Baseline, follow-up assessment (up to 3 months)
Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.
Baseline, follow-up assessment (up to 3 months)
Change in LDL
Time Frame: Baseline, follow-up assessment (up to 3 months)
LDL will be assessed through peripheral blood at the baseline and follow-up assessment
Baseline, follow-up assessment (up to 3 months)
Change in HDL
Time Frame: Baseline, follow-up assessment (up to 3 months)
HDL will be assessed through peripheral blood at the baseline and follow-up assessments.
Baseline, follow-up assessment (up to 3 months)
Change in Triglycerides
Time Frame: Baseline, follow-up assessment (up to 3 months)
Triglycerides will be assessed through peripheral blood at the baseline and follow-up assessments.
Baseline, follow-up assessment (up to 3 months)
Concentration of HbA1c
Time Frame: Baseline, follow-up assessment (up to 3 months)
HbA1c will be assessed through peripheral blood at the baseline and follow-up assessments.
Baseline, follow-up assessment (up to 3 months)
Change in Atherosclerotic Cardiovascular Disease (ASCVD) risk
Time Frame: Baseline, follow-up assessment (up to 3 months)
The 10 year risk for ASCVD is calculated using a patient's age, sex, race, systolic blood pressure, diastolic blood pressure, total cholesterol, HDL, LDL, history of diabetes, smoking status, whether or not they're on hypertension treatment, and whether or not they're on statin.
Baseline, follow-up assessment (up to 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline S Dorfman, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00110049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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