This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
59
12 telehealth sessions. The first 5 visits include psycho/medical education plus a motivational interviewing component. The second 7 sessions include psycho/medical education plus a problem solving training component.
This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations.
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire
Knowledge of nutrition recommendations, as evidenced by scores on the General Nutrition Knowledge Questionnaire - Revised (higher scores indicate greater knowledge).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire
Knowledge of physical activity recommendations, as evidenced by scores on the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire (higher scores indicate greater knowledge).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Physical activity as assessed by Fitbit data
Physical activity total weekly minutes, as evidenced by weekly Fitbit data (activity measured in minutes).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score
Adherence to United States Department of Agriculture recommendations, as evidenced by the Rapid Eating Assessment for Patients (higher scores indicate better adherence to recommendations).
Time frame: Pre-intervention and 2 months after the intervention concludes
Intervention feasibility as assessed by the fidelity rating
Feasibility of conducting the intervention with high clinician fidelity, as evidenced by fidelity ratings for each session (fidelity represented as a percentage based on the extent to which the clinician covered all planned information for each session). Average intervention fidelity ratings should meet or exceed 80% fidelity.
Time frame: Immediately following intervention
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Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
Patient and caregiver acceptability of the newly developed intervention, as evidenced by the Abbreviated Acceptability Rating Profile (higher scores indicate greater acceptability, with scores equal to or greater than 30 indicating good acceptability per published standards).
Time frame: Immediately following intervention
Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form
Self-efficacy managing weight, as evidenced on scores on the Weight Efficacy Lifestyle Questionnaire Short Form (greater scores indicate greater self-efficacy).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II
Self-efficacy maintaining healthy lifestyle behaviors, as evidenced by scores on the Healthy Promoting Lifestyle Profile II ((greater scores indicate greater self-efficacy).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents
Body satisfaction, as evidenced by scores on the Body Esteem Scale for Adults and Adolescents (higher scores indicate greater body satisfaction).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form
Depressive symptoms, as evidenced by scores on the PROMIS Pediatric Depressive Symptoms-Short Form or PROMIS Adult Depressive Symptoms-Short Form (greater scores indicate greater depressive symptoms).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form
PROMIS Pediatric Anxiety Symptoms- Short Form or PROMIS Adult Anxiety Symptoms Short Form (greater scores indicate greater anxiety symptoms).
Time frame: Pre-intervention and 2 months after the intervention concludes
Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale
Self-esteem, as evidenced by scores on the Rosenberg Self Esteem Scale (greater scores indicate greater self-esteem).
Time frame: Pre-intervention and 2 months after the intervention concludes