Pediatric Brain TumorSJNCT07321353
Survivors Journey+
A study testing Survivor's Journey+ in people with Pediatric Brain Tumor, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Pediatric Brain Tumor
- What is being tested?
- Survivor's Journey+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Shari L Wade, PhD, 513-636-3370, shari.wade@cchmc.org
Shari L Wade, PhD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cynthia Gerhardt, PhD, 614-722-4700, cynthia.gerhardt@nationwidechildrens.org
Emily Moscato, PhD, emily.moscato@nationwidechildrens.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Brain Tumor
- Being tested
- Survivor's Journey+
- Keywords
- pediatric brain tumor survivors, online learning, Adolescent young adult, Family, Digital, Problem Solving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivor's Journey+Behavioural
Also called SJ+
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Survivor's Journey+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months post-baseline
Goal Attainment Scaling
Method to establish individualized scales in order to quantify progress toward SMART personal goals.
Measured: From baseline to 6 months post-baseline.
Secondary outcomes (5)
Behavior Rating Inventory of Executive Function, Second Edition T Scores change
Minimum T score of 0, maximum T score of 100. T scores at or above 70 are considered clinically elevated, which is considered worse.
Measured: From baseline to 6 months post-baseline
Behavior Rating Inventory of Executive Function, Second Edition-Adult Version T Scores change
Minimum T score of 0, maximum T score of 100. T scores at or above 70 are considered clinically elevated, which is considered worse.
Measured: From baseline to 6 months post-baseline
Patient-Reported Outcomes Measurement Information System change
Each measure has a range in score from 7 to 35 with higher scores indicating greater severity, which is considered worse.
Measured: From baseline to 6 months post-baseline
Hospital Anxiety and Depression Scale change
Minimum score of 0, maximum score of 42. Higher scores mean greater levels of anxiety and depression, which is considered worse.
Measured: From baseline to 6 months post-baseline
Strength & Difficulties Questionnaire change
Minimum score of 0, maximum score of 40. Higher scores mean greater levels of difficulties, which is considered worse.
Measured: From baseline to 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Shari L Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321353
- Sponsor's protocol ID
- 2024-0546
- Other IDs
- HT9425-24-1-0746
- Acronym
- SJ
- Status last verified
- Jul 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Dept of Defense will not need to see individual participant data from our study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Problem-Solving Intervention for Brain Tumor Survivors: A Two-site, Two-arm Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07321353
- Acronym / sponsor ID
- SJ / 2024-0546
- Conditions
- Pediatric Brain Tumor
- Keywords
- pediatric brain tumor survivors, online learning, Adolescent young adult, Family, Digital, Problem Solving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors Journey Program | Experimental | Behavioral: Survivor's Journey+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. |
| Internet Resources Comparison | Experimental | Behavioral: Survivor's Journey+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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivor's Journey+Also: SJ+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. | Behavioural | Internet Resources Comparison, Survivors Journey Program |
Primary outcome
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.
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.
5 secondary outcomes
Behavior Rating Inventory of Executive Function, Second Edition T Scores change
Time frame: 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
Patient-Reported Outcomes Measurement Information System change
Time frame: From baseline to 6 months post-baseline
Hospital Anxiety and Depression Scale change
Time frame: From baseline to 6 months post-baseline
Strength & Difficulties Questionnaire change
Time frame: From baseline to 6 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. The Dept of Defense will not need to see individual participant data from our study.
Related trials for Pediatric Brain Tumor
RecruitingPhase 2
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
Diffuse Intrinsic Pontine Glioma, DIPG
Not yet recruitingPhase 2
Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)
High Grade Glioma (HGG) of the Brain With BRAF Aberration, High Grade Glioma (III or IV)
Recruiting
Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia
Acute Leukemia, Acute Lymphoblastic Leukemia, Pediatric
RecruitingPhase 3
Dexmedetomidine Use for Greater Occipital Nerve Block in Pediatric Posterior Fossa Tumor Surgery.
Posterior Fossa Tumor
Active, not recruitingPhase 1
Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari L Wade, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivor's Journey+ in people with Pediatric Brain Tumor, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shari L Wade, PhD (513-636-3370, shari.wade@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory Total Scale Score change (time frame: From baseline to 6 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.