Survivors Journey+

NCT07321353 | Recruiting

• 2 other identifiers: 2024-0546HT9425-24-1-0746
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pediatric Quality of Life Inventory Total Scale Score change

  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

  Method to establish individualized scales in order to quantify progress toward SMART personal goals.

  From baseline to 6 months post-baseline.

Secondary Outcomes (5)

• Behavior Rating Inventory of Executive Function, Second Edition T Scores change

  From baseline to 6 months post-baseline

• Behavior Rating Inventory of Executive Function, Second Edition-Adult Version T Scores change

  From baseline to 6 months post-baseline

• Patient-Reported Outcomes Measurement Information System change

  From baseline to 6 months post-baseline

• Hospital Anxiety and Depression Scale change

  From baseline to 6 months post-baseline

• Strength & Difficulties Questionnaire change

  From baseline to 6 months post-baseline

Study Arms (2)

Survivors Journey Program

EXPERIMENTAL

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+

Internet Resources Comparison

EXPERIMENTAL

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+

Interventions

Survivor's Journey+ BEHAVIORAL

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.

Also known as: SJ+

Internet Resources Comparison; Survivors Journey Program

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Nationwide Children's Hospital: collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Study Officials

• Shari L Wade, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shari L Wade, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)