The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for adolescent and young adult cancer survivors compared to a self-guided arm. Participants, diagnosed with cancer between ages 15-39, currently age 18-39, post-treatment at least 6 months, and who have overweight or obesity will be randomized to receive either: 1) a comprehensive mHealth weight management program (intervention) or 2) digital tools + health education + peer support (self-guided) over 12 months. Outcomes will be assessed at 3, 6, and 12 months.
18-39 years old at the time of consent.
Diagnosed with first invasive cancer between ages 15-39 years (self-report).
Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers (self-report).
Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) at least six months prior to enrollment; may be receiving "maintenance" therapy to prevent recurrences (self-report).
Type 1 diabetes or currently receiving certain medical treatments for Type 2 diabetes
Report a history of heart attack or stroke within previous 6 months
Health problems which preclude ability to walk for physical activity (e.g., lower limb amputation). Participants endorsing items 1-4 on the Physical Activity Readiness Questionnaire (PAR-Q) (experience of heart problems, frequent chest pains, or faintness or dizziness) will be excluded from the study.
Lost 5% or more of body weight (and kept it off) in the last 3 months
Parallel
AYA WELL Intervention
BehavioralBehavioral weight management intervention for adolescent and young adult cancer survivors with digital tools, smartphone web app behavioral program, text messages, and expert-guided closed social networking group for peer support.
Self-Guided
BehavioralSelf-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.
Weight change percent
Change in weight (%) from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home for remote participants and in the clinic for in person assessments. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))\*100.
Weight maintenance percent
Weight will be objectively measured on a digital scale in the participant's home for remote participants and in the clinic for clinic subsample. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))\*100. Maintenance of weight change is measured from 6 to 12 months.
Body Mass Index (BMI)
Change in body mass index is calculated as weight in kg divided by the square of height in meters. BMI is calculated at each weight assessment and change over time is assessed.
Health-related quality of life
Change in health-related quality of life is measured using the Medical Outcomes Study 36-Item Short Form (SF-36) survey. This survey includes 36 items with eight subscales (physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions). Responses are coded on a scale of 0 to 100, where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.
Diet quality
Diet Quality id assessed using the Healthy Eating Index (HEI) using data from the National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA-24). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome. Participants complete a weekday and weekend day recall at baseline, 6, and 12 months and change over time is assessed.
Depressive Symptoms
The Center for Epidemiological Studies Depression Scale (CES-D) will be used to examine levels of depressive symptoms. The CES-D is a self-report scale designed to measure depression symptoms in the general population. The self-test measure includes 20 items that relate to depressive feelings and behaviors during the past week. Items are scored on a range of 0 (rarely or none of the time) to 3 (most or all of the time) with values ranging from 0 to 60. Higher values indicate more depressive symptoms. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.
Perceived Stress
The 10-item Perceived Stress Scale (PSS-10) measures overall perceived stress during the past month. Items are scored on a 5-point Likert scale from 0 (Never) to 4 (Very Often) with total scores ranging from 0 to 40. Items 4, 5, 7 and 8 are reverse scored. Higher scores indicate higher levels of perceived stress. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.
Anxiety
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-report measure of generalized anxiety symptoms.183 Possible scores range from 0 to 21, with higher scores reflecting greater symptom severity; cut-points of 5, 10, and 15 correspond to mild, moderate, and severe levels of anxiety. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.
Global Health
The patient-reported outcomes measurement information system (PROMIS) Global Health measure be used to measure perceptions of health. The PROMIS measure consists of 10 self-reported global health items, which assess 5 domains: physical function, pain, fatigue, emotional distress, and social health. The response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher values indicate better health. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
Virginia Commonwealth University
Collaborator
National Cancer Institute (NCI)
Collaborator
