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

Pain Clinical Trial

— HEALTHY-AYA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869604
• Other study ID #: Pro00110049
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: Caroline S Dorfman, PhD
• Phone: 919-416-3473
• Email: caroline.dorfman[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• History of cancer
• Diagnosed with cancer between the ages of 18 and 39
• Within 2 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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale	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)
Other	Change in Self-Efficacy for weight management: Weight efficacy Lifestyle questionnaire- short form	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)
Other	Change in blood pressure (systolic and dyastolic)	Both systolic and dyastolic blood pressure will be assessed at the baseline and follow-up assessment.	Baseline, follow-up assessment (up to 3 months)
Other	Change in total cholesterol	Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.	Baseline, follow-up assessment (up to 3 months)
Other	Change in LDL	LDL will be assessed through peripheral blood at the baseline and follow-up assessment	Baseline, follow-up assessment (up to 3 months)
Other	Change in HDL	HDL will be assessed through peripheral blood at the baseline and follow-up assessments.	Baseline, follow-up assessment (up to 3 months)
Other	Change in Triglycerides	Triglycerides will be assessed through peripheral blood at the baseline and follow-up assessments.	Baseline, follow-up assessment (up to 3 months)
Other	Concentration of HbA1c	HbA1c will be assessed through peripheral blood at the baseline and follow-up assessments.	Baseline, follow-up assessment (up to 3 months)
Other	Change in Atherosclerotic Cardiovascular Disease (ASCVD) risk	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)
Primary	Feasibility of study recruitment	Number of participants recruited over the course of 12 months.	12 months
Primary	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)
Primary	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)
Primary	Intervention acceptability: Treatment Acceptability Questionnaire	The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective.; Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable).	Following completion of the intervention (up to 3 months)
Primary	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)
Primary	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	Change in diet and eating behavior: Three factor eating questionnaire	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)
Secondary	Change in weight	Participants will be weighed at each assessment.	Baseline, follow-up assessment (up to 3 months)
Secondary	Change in diet: Dietary screener questionnaire	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)
Secondary	Change in Physical Activity: Stanford L-Cat	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)
Secondary	Change in Pain: Brief Pain Inventory (BPI)	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)
Secondary	Change in Fatigue: PROMIS Fatigue Scale	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)
Secondary	Change in Depressive Symptoms: PROMIS Depression Short Form	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)
Secondary	Change in Anxiety: PROMIS Anxiety Short Form	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)