Survivors Journey+ (SJ)

December 22, 2025 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pediatric brain tumor survivors (PBTS) experience worse outcomes compared to other survivors or healthy adolescents and young adults. This includes quality of life (QoL), neurocognitive late effects, declines in IQ, executive functioning (EF), and social problem-solving skills. As adolescents navigate academic and social challenges, neurocognitive late effects place PBTS at elevated risk for impaired functioning during this critical transition. Equipping PBTS and their caregivers with a set of skills to manage stress, solve problems, and address neurocognitive and social challenges may promote better outcomes and prevent further declines in QoL. Prior research has targeted the survivor or caregiver in isolation, and not as family-centered treatment.

PBTS assume the largest burden of late effects from childhood cancer, with few effective solutions to address their lifelong challenges. Caregivers and families also experience stress and burden that can impact everyday functioning. Survivor's Journey Plus (SJ+) addresses this urgent need by offering a developmentally tailored, family-centered approach to improving social problem-solving, emotion-regulation, and metacognitive skills in PBTS, while offering strategies to reduce caregiver depression and family impact.

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. Importantly, we will consider improvements in both patient-reported and performance-based outcomes. We will conduct a two-site, two-arm pilot RCT (n = 72) comparing SJ+ to an internet resource comparison (IRC) with outcomes assessed at baseline, treatment completion (~ 3 months post-baseline), and 6 months post-baseline.

SJ+ provides training in contextualized metacognitive strategies and communication skills to address common challenges (e.g., working memory, attention/planning, social communication) in the context of a broader social problem-solving framework. It is predicated on more than two decades of research with pediatric brain injury survivors, demonstrating its feasibility, acceptability, and efficacy among adolescents and young adults.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • SJ+
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.
Behavioral: 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.
Other Names:
  • SJ+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory Total Scale Score change
Time Frame: From baseline to 6 months post-baseline
Minimum score of 0, maximum score of 100. A higher score indicates better Health-Related Quality of Life, which is considered better.
From baseline to 6 months post-baseline
Goal Attainment Scaling
Time Frame: From baseline to 6 months post-baseline.
Method to establish individualized scales in order to quantify progress toward SMART personal goals.
From baseline to 6 months post-baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior Rating Inventory of Executive Function, Second Edition T Scores change
Time Frame: From baseline to 6 months post-baseline
Minimum T score of 0, maximum T score of 100. T scores at or above 70 are considered clinically elevated, which is considered worse.
From baseline to 6 months post-baseline
Behavior Rating Inventory of Executive Function, Second Edition-Adult Version T Scores change
Time Frame: From baseline to 6 months post-baseline
Minimum T score of 0, maximum T score of 100. T scores at or above 70 are considered clinically elevated, which is considered worse.
From baseline to 6 months post-baseline
Patient-Reported Outcomes Measurement Information System change
Time Frame: From baseline to 6 months post-baseline
Each measure has a range in score from 7 to 35 with higher scores indicating greater severity, which is considered worse.
From baseline to 6 months post-baseline
Hospital Anxiety and Depression Scale change
Time Frame: From baseline to 6 months post-baseline
Minimum score of 0, maximum score of 42. Higher scores mean greater levels of anxiety and depression, which is considered worse.
From baseline to 6 months post-baseline
Strength & Difficulties Questionnaire change
Time Frame: From baseline to 6 months post-baseline
Minimum score of 0, maximum score of 40. Higher scores mean greater levels of difficulties, which is considered worse.
From baseline to 6 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Shari L Wade, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-0546
  • HT9425-24-1-0746 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Dept of Defense will not need to see individual participant data from our study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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