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

NCT04839952 | Completed

• 1 other identifier: IRB00238848
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

Pediatric cancer; Survivorship; Child; Adolescent; Weight; Obesity; Physical activity; Motivational interviewing; Problem solving; Culture; Exercise; Nutrition

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Change in Healthy lifestyle self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire Short Form

  Pre-intervention and 2 months after the intervention concludes

• Change in Healthy lifestyle self-efficacy as assessed by the Healthy Promoting Lifestyle Profile II

  Pre-intervention and 2 months after the intervention concludes

• Change in Body satisfaction as assessed by the Body Esteem Scale for Adults and Adolescents

  Pre-intervention and 2 months after the intervention concludes

• Change in Depression as assessed by the PROMIS Depressive Symptoms-Short Form

  Pre-intervention and 2 months after the intervention concludes

• Change in Anxiety as assessed by the PROMIS Anxiety Symptoms- Short Form

  Pre-intervention and 2 months after the intervention concludes

Study Arms (2)

Healthy Lifestyles Intervention Arm

EXPERIMENTAL

Participants will receive the healthy lifestyles intervention.

Behavioral: Healthy Lifestyles

Education-Only Control Arm

ACTIVE COMPARATOR

Participants will receive the education-only intervention.

Behavioral: Education-Only Control

Interventions

Healthy Lifestyles BEHAVIORAL

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.

Healthy Lifestyles Intervention Arm

Education-Only Control BEHAVIORAL

This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations.

Education-Only Control Arm

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Neoplasms; Body Weight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Melissa A. Faith, Ph.D., ABPP

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a small feasibility study. We will enroll 24 participants on the intervention arm and 12 participants to an education-only control arm.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: June 11, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

US (1)