Survivors Journey+
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Study ID
- NCT07321353
- Status
- Recruiting
Conditions
- Pediatric Brain Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 25 Years
- Healthy Volunteers
- Not accepted
Interventions
- Survivor's Journey+ — BEHAVIORALOur overarching objectives are to: 1) to refine the existing program based on feedback from patient advocates and establish usability and accessibility; 2) examine the efficacy of SJ+ in improving global QoL, internalizing symptoms, and EF skills in adolescent/emerging adult PBTS; and 3) examine the efficacy of SJ+ in reducing caregiver depression and family impact.
Study Details
The main goal of this pilot randomized controlled trial is to learn if an online program called "Survivors Journey" (SJ+) can help teens and young adults, ages 15-25, who are Pediatric Brain Tumor Survivors (PBTS), and their caregivers, manage everyday challenges better by using skills like problem-solving and coping skills. The main questions it aims to answer are: * Is the SJ+ program rated as feasible (\>50% enrollment rate and \>75% retention rate) and acceptable (\>80% satisfaction rate) by PBTS and their caregivers? * Does the SJ+ program have better outcomes in improving PBTS and caregiver wellbeing in comparison to an internet resource comparison (IRB) made for PBTS and their families? Participants will be randomized into two groups: one group will be given access to the online SJ+ program and receive weekly online coaching sessions, and the other group will be given access to an IRC. Outcomes will be assessed at baseline, treatment completion (\~ 3 months post-baseline), and at follow-up six months post-baseline. These outcomes include quality of life, internalizing symptoms, performance-based executive function skills, depression, and family impact.
Key Dates
- Start date
- Aug 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Survivors Journey ProgramThe Survivor's Journey+ (SJ+) intervention seeks to address "gaps in quality of life and/or survivorship that may impact mission readiness and the health and well-being of military members, Veterans, their beneficiaries, and the general public" by providing training in stress management, problem-solving, metacognitive strategies, self-regulation, and communication in the context of a contextualized, developmentally tailored intervention to address the multifaceted challenges facing adolescent/emerging adult PBTS and their families.
- Experimental: Internet Resources ComparisonIRC families will receive access to a home page of pediatric brain tumor survivor resources and links (identical to those given on the SJ+ homepage) but will not be able to access specific session content. This will enable us to equate the groups with respect to access to the information and resources available on the Web.
Primary Outcome Measure
Pediatric Quality of Life Inventory Total Scale Score change [ Time Frame: From baseline to 6 months post-baseline ]
Central Contacts
- Shari L Wade, PhD513-636-3370
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Shari L Wade, PhD (PRINCIPAL_INVESTIGATOR) |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Emily Moscato, PhD Cynthia Gerhardt, PhD (PRINCIPAL_INVESTIGATOR) |
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