Clinical trial NCT05869604: Healthy Lifestyles After Cancer for Adolescents and Young Adults: A Program to Reduce Cardiovascular Risk Factors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Cardiovascular Diseases
Weight Management
Pain
Fatigue
Distress, Emotional
Physical Inactivity
Keywords: AYA Cancer Survivors
Symptom management
Health Behavior Change
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of study recruitment
timeFrame: 12 months
measure: Session attendance
timeFrame: Following completion of the intervention (up to 3 months)
measure: Participant attrition
timeFrame: Following completion of the intervention (up to 3 months)
measure: Intervention acceptability: Treatment Acceptability Questionnaire
timeFrame: Following completion of the intervention (up to 3 months)
measure: Intervention satisfaction: SSTS-R
timeFrame: Following completion of the intervention (up to 3 months)
measure: Open-Ended Questions About the Program
timeFrame: Following completion of the intervention (up to 3 months)
Secondary outcomes:
measure: Change in diet and eating behavior: Three factor eating questionnaire
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in weight
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in diet: Dietary screener questionnaire
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Physical Activity: Stanford L-Cat
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Pain: Brief Pain Inventory (BPI)
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Fatigue: PROMIS Fatigue Scale
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Depressive Symptoms: PROMIS Depression Short Form
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Anxiety: PROMIS Anxiety Short Form
timeFrame: Baseline, follow-up assessment (up to 3 months)
Other outcomes:
measure: Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Self-Efficacy for weight management: Weight efficacy Lifestyle questionnaire- short form
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in blood pressure (systolic and dyastolic)
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in total cholesterol
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in LDL
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in HDL
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Triglycerides
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Concentration of HbA1c
timeFrame: Baseline, follow-up assessment (up to 3 months)
measure: Change in Atherosclerotic Cardiovascular Disease (ASCVD) risk
timeFrame: Baseline, follow-up assessment (up to 3 months)
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Caroline S Dorfman, PhD
role: PRINCIPAL_INVESTIGATOR
References: