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

NCT ID: NCT04839952

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2023-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Lifestyles Intervention Arm

Participants will receive the healthy lifestyles intervention.

Group Type: EXPERIMENTAL

Healthy Lifestyles

Intervention Type: 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.

Education-Only Control Arm

Participants will receive the education-only intervention.

Group Type: ACTIVE_COMPARATOR

Education-Only Control

Intervention Type: BEHAVIORAL

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

Interventions

Healthy Lifestyles

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.

Intervention Type: BEHAVIORAL

Education-Only Control

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa A. Faith, Ph.D., ABPP

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

IRB00238848

Identifier Type: -

Identifier Source: org_study_id