| NCT ID | NCT07321353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Pediatric Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-08-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Shari L Wade, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT07321353 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 25 Years, studying Pediatric Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07321353 currently recruiting?
Yes, NCT07321353 is actively recruiting participants. Contact the research team at shari.wade@cchmc.org for enrollment information.
Where is the NCT07321353 trial being conducted?
This trial is being conducted at Cincinnati, United States, Columbus, United States.
Who is sponsoring the NCT07321353 clinical trial?
NCT07321353 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Shari L Wade, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 72 participants.