Digital Self-Management and Peer Mentoring Intervention

NCT06763770 | Enrolling By Invitation DMC

• 2 other identifiers: Pro2023000838R01CA282147
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Cancer Survivor; Survivorship; Cancer

Keywords

Pediatric cancer survivors; Self-management; Young adults; Childhood cancer survivors; Transition; Peer mentor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adherence to guideline-concordant survivorship care

  Baseline, 12 months

• Health-related Quality of Life

  Baseline, 3 months, 12 months

Study Arms (2)

Managing Your Health (MYH)

EXPERIMENTAL

The Managing Your Health app + Peer Mentoring Intervention

Behavioral: Managing Your Health (MYH)

Usual Care + Educational Control

ACTIVE COMPARATOR

The Usual Care + Educational Control

Behavioral: The Usual Care + Educational Control

Interventions

Managing Your Health (MYH) BEHAVIORAL

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.

Managing Your Health (MYH)

The Usual Care + Educational Control BEHAVIORAL

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).

Usual Care + Educational Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• University of Southern California: collaborator
• Children's Hospital Los Angeles: collaborator

Study Sites (2)

University of South California

Los Angeles, California, 900339239, United States

Location

Rutgers Cancer Institute

New Brunswick, New Jersey, 089011914, United States

Location

Related Publications (1)

• 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.

  PMID: 41442700 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kristine Levonyan-Radloff, MS

  Rutgers Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 1 year after publication with no end date
• 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.

Locations

US (2)