An interventional study of Managing Your Health (MYH) and The Usual Care + Educational Control in Pediatric Cancer Survivor, Survivorship and Cancer, sponsored by Rutgers, The State University of New Jersey. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Supportive care
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 300 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
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Exclusion Criteria:
The Managing Your Health app + Peer Mentoring Intervention
Behavioral: Managing Your Health (MYH)
The Usual Care + Educational Control
Behavioral: The Usual Care + Educational Control
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.
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).
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.
Time frame: Baseline, 3 months, 12 months
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.
Time frame: 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.
Time frame: Baseline, 3 months, 12 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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Rutgers, The State University of New Jersey