Digital Self-Management and Peer Mentoring Intervention

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 hea
• Поведенческое 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

Первичные конечные точки

• Self-Management behaviors [Срок оценки: Baseline, 3 months, 12 months]

Вторичные конечные точки (2)

• Adherence to guideline-concordant survivorship care [Срок оценки: Baseline, 12 months]
• Health-related Quality of Life [Срок оценки: Baseline, 3 months, 12 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• University of South California — Los Angeles
• Rutgers Cancer Institute — New Brunswick

Публикации

• 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

Идентификаторы

NCT: NCT06763770 · Pro2023000838 · R01CA282147

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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