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

Johns Hopkins Medicine

Status: Completed

Conditions: Pediatric Cancer

Treatments: Behavioral: Healthy Lifestyles; Behavioral: Education-Only Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04839952

IRB00238848

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Healthy Lifestyles Intervention Arm

Experimental group

Description:

Participants will receive the healthy lifestyles intervention.

Treatment:

Behavioral: Healthy Lifestyles

Education-Only Control Arm

Active Comparator group

Description:

Participants will receive the education-only intervention.

Treatment:

Behavioral: Education-Only Control