Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer

Study Overview
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Brief Summary
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This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.

Official Title
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Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Behavioral: Healthy Lifestyles
* Behavioral: Education-Only Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be adolescents and young adults (15-25 years of age) who have completed cancer treatment at Johns Hopkins All Children's Hospital any time in the last five years. This age range was chosen because it corresponds to the recommended age range for cancer-related adolescents and young adult studies38. If the adolescent or young adult patient lives with a parent, other adult family member, or adult romantic/platonic partner, that person will also be invited to participate in the intervention as a support to the patient. If the adolescent or young adult patient lives with a parent or romantic partner, the parent or romantic partner will also be invited to participate in the intervention as a support to the patient. A parent or romantic partner is eligible to participate if the patient lives with them at least 50% of the time. The parent or romantic partner will not receive separate financial compensation for participation. Herein, we use the word parent only because we expect the vast majority of patients will live with a parent instead of a romantic partner. Patients who do not live with a parent or romantic partner will participate alone. The patient's cancer treatment must have included chemotherapy and/or radiation. If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention. Exclusion Criteria: Potential participants who appear to have cognitive, motor, or language delays, as observed by research personnel or documented in the medical record, will be excluded from this study if delays preclude informed consent and/or study completion. Participants may request that research personnel read all assessment, education, and intervention materials aloud in a structured interview format, in which case participants could respond to items verbally and/or by pointing to visual aids. Because of this option, participants' ability to read and write are not requirements for participation. Because the motivational interviewing component of the intervention is language-dependent and requires significant time and training for certification in another language, non-English speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker and can demonstrate motivational interviewing proficiency in Spanish.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a small feasibility study. We will enroll 24 participants on the intervention arm and 12 participants to an education-only control arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Lifestyles Intervention Arm<br>Participants will receive the healthy lifestyles intervention. | Behavioral: Healthy Lifestyles<br>* 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.<br>|
| Active Comparator: Education-Only Control Arm<br>Participants will receive the education-only intervention. | Behavioral: Education-Only Control<br>* This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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. | Immediately following intervention | 
| 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). | Immediately following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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). | Pre-intervention and 2 months after the intervention concludes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric cancer, Survivorship, Child, Adolescent, Weight, Obesity, Physical activity, Motivational interviewing, Problem solving, Culture, Exercise, Nutrition