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Clinical Trials/NCT06763770
NCT06763770
Enrolling By Invitation
Not Applicable

Digital Self-Management and Peer Mentoring Intervention to Improve the Transition From Pediatric to Adult Health Care for Childhood Cancer Survivors

Rutgers, The State University of New Jersey4 sites in 1 country300 target enrollmentMarch 4, 2025

Overview

Phase
Not Applicable
Intervention
Managing Your Health (MYH)
Conditions
Pediatric Cancer Survivor
Sponsor
Rutgers, The State University of New Jersey
Enrollment
300
Locations
4
Primary Endpoint
Self-Management behaviors
Status
Enrolling By Invitation
Last Updated
19 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2025
End Date
July 1, 2028
Last Updated
19 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katie Devine, PhD, MPH

Associate Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Managing Your Health (MYH)

The Managing Your Health app + Peer Mentoring Intervention

Intervention: Managing Your Health (MYH)

Usual Care + Educational Control

The Usual Care + Educational Control

Intervention: The Usual Care + Educational Control

Outcomes

Primary Outcomes

Self-Management behaviors

Time Frame: Baseline, 3 months, 12 months

The Self-Management Skills scale is a 15-item measure about a patient's active behaviors in managing their health. Response options were modified such that participants respond on a 5-point scale from 1 (not at all) to 5 (completely) regarding their agreement to each item. Example items include "I participate in making decisions about my health" and "I book my own doctor's appointments." A total mean score will be used, which could range from 0 to 5. Higher scores indicate better self-management behaviors.

Secondary Outcomes

  • Adherence to guideline-concordant survivorship care(Baseline, 12 months)
  • Health-related Quality of Life(Baseline, 3 months, 12 months)

Study Sites (4)

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