Digital Self-Management and Peer Mentoring Intervention

Not Applicable

• Conditions: Pediatric Cancer Survivor; Survivorship; Cancer

• Registration Number: NCT06763770
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Status Verified: 2025-03
• Study Start: 2025-03-04
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2028-01
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-Management behaviors	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 Outcome Measures

Name	Time	Method
Adherence to guideline-concordant survivorship care	Baseline, 12 months	Participants will report on cancer-specific and general medical appointments, surveillance tests, cancer screenings, and detection of new comorbidities using items from the Follow-Up Care Use Among Survivors (FOCUS) survey developed by NCI and items from surveys in the Childhood Cancer Survivor Study. Given the purposeful heterogeneity of our sample, we focus on the most common surveillance recommendations. We will report separately on receipt of cancer-related follow-up care (yes/no) and survivorship care plan (yes/no). For other tests, participants will be deemed adherent if they are up-to-date on recommended tests based on their health history. A summary score will be calculated for each participant by dividing the total number of recommendations completed by the total number of guideline-recommended tests. Thus, each participant will have a score that could range from 0 to 1, with 0 indicating no engagement in care and 1 indicating fully adherent to guideline concordant care.
Health-related Quality of Life	Baseline, 3 months, 12 months	The Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure is a 10-item measure that assesses self-rated health, physical quality of life, mental quality of life, fatigue, pain, and participation in social activities and roles. The PROMIS measures have undergone extensive testing and are widely used. The Global Health measure yields a Physical Summary and Mental Health Summary scores, in addition to the total score. We will use the total score, which is standardized as a T-score with a mean of 50 and standard deviation of 10.

Trial Locations

Locations (2)

University of South California; 🇺🇸 Los Angeles, California, United States

Rutgers Cancer Institute; 🇺🇸 New Brunswick, New Jersey, United States