Clinical trial NCT06763770: Digital Self-Management and Peer Mentoring Intervention
Official title: Digital Self-Management and Peer Mentoring Intervention to Improve the Transition From Pediatric to Adult Health Care for Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pediatric Cancer Survivor
Survivorship
Cancer
Keywords: Pediatric cancer survivors
Self-management
Young adults
Childhood cancer survivors
Transition
Peer mentor
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Southern California
name: Children's Hospital Los Angeles
First posted: 2025-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests how helpful a digital self-management and peer mentoring program is to young adult survivors of childhood cancer to improve their ability to manage their survivorship care as they transition from pediatric to adult-oriented follow-up care. Survivors require lifelong "risk-based" follow-up care based on the treatment they received to identify and treat late health effects. The transition from pediatric to adult follow-up care is a critical period when many survivors are lost to follow-up. Barriers to successful transition and engagement in care include poor knowledge of cancer history, low healthcare self-efficacy, poor self-management skills, low health literacy, and access issues such as financial hardship, insurance, and distance from cancer center. The "Managing Your Health" digital self-management and peer mentoring program aims to address these gaps and improve survivorship care self-management. Improvements in healthcare self-management are necessary to keep young adult survivors engaged in recommended health care, improve their quality of life, and promote optimal health.

Detailed description: The purpose of the study is to determine the efficacy of the Managing Your Health intervention to improve self-management of survivorship care among young adult survivors of childhood cancer.

Aim 1: Evaluate the efficacy of the Managing Your Health intervention. Aim 2: Determine the mechanisms through which Managing Your Health influences outcomes.

Aim 3: Identify subgroups of participants for which treatment effects vary to inform future scale up.

Managing Your Health will be tested in a two-arm parallel randomized controlled trial (RCT) of the intervention versus usual care + educational control with 300 young adult survivors of childhood cancer currently aged 18-25 years. Participants will complete outcome measures at baseline, 3 months, and 12 months post-randomization.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis with any malignant childhood cancer between the ages 0-19 at least 5 years prior
2. Cancer treatment occurred at a pediatric center/facility
3. Current age 18-25
4. At least 2 years from treatment completion (typical time for transfer to long-term follow-up care)

Exclusion Criteria:

1. Any documented physical or self-reported cognitive delay that could prevent self-management of health care
2. Diagnoses of cancer not typically considered pediatric (I.e., melanoma, carcinoma of the breast, colorectum, lung, ovary, and testicle)
3. Unable to speak/read English

Primary outcomes:
measure: Self-Management behaviors
timeFrame: Baseline, 3 months, 12 months
Secondary outcomes:
measure: Adherence to guideline-concordant survivorship care
timeFrame: Baseline, 12 months
measure: Health-related Quality of Life
timeFrame: Baseline, 3 months, 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of South California
state: California
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute
name: Kristine Levonyan-Radloff, MS
role: STUDY_DIRECTOR
References: