Clinical trial NCT04839952: Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer
Official title: Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: Pediatric cancer
Survivorship
Child
Adolescent
Weight
Obesity
Physical activity
Motivational interviewing
Problem solving
Culture
Exercise
Nutrition
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 59
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Nutrition knowledge as assessed by the General Nutrition Knowledge Questionnaire
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Physical activity knowledge as assessed by the Knowledge of American Heart Association Physical Activity Recommendations Questionnaire
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Physical activity as assessed by Fitbit data
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Nutrition as assessed by the Rapid Eating Assessment for Patients score
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Intervention feasibility as assessed by the fidelity rating
timeFrame: Immediately following intervention
measure: Intervention acceptability as assessed by the Abbreviated Acceptability Rating Profile
timeFrame: Immediately following intervention
Secondary outcomes:
measure: Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form
timeFrame: Pre-intervention and 2 months after the intervention concludes
measure: Change in Self-esteem as assessed by the Rosenberg Self Esteem Scale
timeFrame: Pre-intervention and 2 months after the intervention concludes
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Melissa A. Faith, Ph.D., ABPP
role: PRINCIPAL_INVESTIGATOR
References: