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Online Problem-Solving Intervention for Brain Tumor Survivors: A Two-site, Two-arm Pilot Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 25
Healthy Volunteers: f
View:

• a diagnosis of a pediatric intracranial tumor

• tumor-directed treatment completed \> 12 months ago (treatment included: surgery, radiation, or chemotherapy)

• lives with parent/guardian(s)

• language: English must be the primary spoken language in the home

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Shari L Wade, PhD
shari.wade@cchmc.org
513-636-3370
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-09
Participants
Target number of participants: 72
Treatments
Experimental: Survivors Journey Program
The 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 Comparison
IRC 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.
Related Therapeutic Areas
Sponsors
Collaborators: Nationwide Children's Hospital
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov