Digital Self-Management and Peer Mentoring Intervention

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer; Survivorship; Pediatric Cancer Survivor
• Intervention / Treatment: Behavioral: Managing Your Health (MYH); Behavioral: The Usual Care + Educational Control

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 900339239
      • University of South California
  • New Jersey
    • New Brunswick, New Jersey, United States, 089011914
      • Rutgers Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Managing Your Health (MYH); The Managing Your Health app + Peer Mentoring Intervention	Behavioral: Managing Your Health (MYH); The Managing Your Health intervention consists of six weekly videoconference calls with a peer mentor and five self-management educational modules within a mobile application. The first call is to get to know each other, share survivorship stories, identify self-management strengths and weaknesses, and select goals for participation in the intervention. The remaining five weekly calls cover a self-management topic each week, including understanding your survivorship care plan, navigating the healthcare system and insurance, managing the emotional aspects of survivorship, negotiating family and significant other involvement in care, and engaging in healthy lifestyle behaviors.
Active Comparator: Usual Care + Educational Control; The Usual Care + Educational Control	Behavioral: The Usual Care + Educational Control; The Usual Care + Educational Control group will receive weekly emails with links to the Health Links developed by the Children's Oncology Group for use in survivorship care. Access to these Health Links reflects the current state of clinical care available to survivors. These Health Links were developed as patient education materials to cover relevant self-management and survivorship care topics. The weekly messages will align with the content of the modules from Managing Your Health to provide similar information, including Introduction to Long-Term Follow-Up (Module 1), Finding and Paying for Healthcare (Module 2), Emotional Issues (Modules 3 and 4), Educational Issues, Diet and Physical Activity, Skin Health, Reducing the Risk of Second Cancers, and Male/Female Health Issues (Module 5).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Management behaviors	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.	Baseline, 3 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to guideline-concordant survivorship care	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.	Baseline, 12 months
Health-related Quality of Life	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.	Baseline, 3 months, 12 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); University of Southern California; Children's Hospital Los Angeles
• Investigators: Study Director: Kristine Levonyan-Radloff, MS, Rutgers Cancer Institute

Publications and helpful links

General Publications

• Collins MKR, Levonyan-Radloff K, McLaughlin J, Masterson M, Devine KA. Designing an App to Facilitate Self-Management in Young Adult Survivors of Childhood Cancer: Development and Usability Study. JMIR Cancer. 2025 Dec 24;11:e77121. doi: 10.2196/77121.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Transition; Self-management; Young adults; Childhood cancer survivors; Peer mentor; Pediatric cancer survivors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Pro2023000838; R01CA282147 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The proposed research will collect self-reported and medical-record data from 300 AYA survivors of childhood cancer. The final dataset will include self-reported demographic, psychosocial, and behavioral data from surveys as well as records of healthcare utilization. Documentation of the variables included in the dataset will be provided with the dataset.
• IPD Sharing Time Frame: Beginning 1 year after publication with no end date
• IPD Sharing Access Criteria: Even with removal of all identifiers, we believe there remains a very small possibility of identifying subjects with unusual characteristics. Therefore, we will make de-identified data available to qualified individuals within the scientific community for research purposes under a data-sharing agreement that specifies that data will only be used for research purposes, transfer of data will be done through secure methods, and investigators will commit to destroying copies of the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No