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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Duke University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Open-Ended Questions About the Program
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of cancer
- •Diagnosed with cancer between the ages of 18 and 39
- •Within 5 years of completing cancer treatments
- •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
Outcomes
Primary Outcomes
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?"
Intervention acceptability: Treatment Acceptability Questionnaire
Time Frame: Following completion of the intervention (up to 3 months)
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").
Feasibility of study recruitment
Time Frame: 12 months
Number of participants recruited over the course of 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.
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
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."
Secondary Outcomes
- Change in diet: Dietary screener questionnaire(Baseline, follow-up assessment (up to 3 months))
- Change in Pain: Brief Pain Inventory (BPI)(Baseline, follow-up assessment (up to 3 months))
- Change in Depressive Symptoms: PROMIS Depression Short Form(Baseline, follow-up assessment (up to 3 months))
- 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 Physical Activity: Stanford L-Cat(Baseline, follow-up assessment (up to 3 months))
- Change in Fatigue: PROMIS Fatigue Scale(Baseline, follow-up assessment (up to 3 months))
- Change in Anxiety: PROMIS Anxiety Short Form(Baseline, follow-up assessment (up to 3 months))