Recruiting

Survivors Journey

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07321353

Conditions

Pediatric Brain Tumor

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

Survivor's Journey+

Study Details

Brief 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.

Conditions

Pediatric Brain Tumor

Study ID

NCT07321353

Start date

Aug 1, 2025

Status verified date

Jul, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Survivor'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.

Primary outcome measure

  • Pediatric Quality of Life Inventory Total Scale Score change [ Time Frame: From baseline to 6 months post-baseline ]
  • Goal Attainment Scaling [ Time Frame: From baseline to 6 months post-baseline. ]

Central Contacts and Locations

Central contacts

Shari L Wade, PhD

513-636-3370shari.wade@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Shari L Wade, PhD

513-636-3370shari.wade@cchmc.org

Principal Investigator:

Shari L Wade, PhD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Cynthia Gerhardt, PhD

614-722-4700cynthia.gerhardt@nationwidechildrens.org

Emily Moscato, PhD

emily.moscato@nationwidechildrens.org

Principal Investigator:

Cynthia Gerhardt, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jan 7, 2026

Last verified

Jul, 2025

Keywords

  • pediatric brain tumor survivors
  • online learning
  • Adolescent young adult
  • Family
  • Digital
  • Problem Solving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-01-07.