RecruitingNot ApplicableNCT07321353

Survivors Journey+

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

72 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 15 YearsMax Age: 25 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • history of tuberous sclerosis or neurofibromatosis
  • treatment \< 12 months ago and/or treatment did not include surgery, radiation, or chemotherapy
  • history of psychiatric hospitalization
  • resides outside of the family home
  • history of autism, reactive attachment disorder, psychosis, or other psychiatric diagnoses/conditions associated with significant risk of harm to self or others per caregiver
  • English is not the primary language spoken in the home

Interventions

BEHAVIORALSurvivor's Journey+

Our 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.


Locations(2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

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NCT07321353


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