Survivors Journey+
ConditionPediatric Brain Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorChildren's Hospital Medical Center, Cincinnati
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Survivor's Journey+
BehavioralOur 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Survivors Journey ProgramExperimental treatment 1 intervention
Group B: Internet Resources ComparisonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to 6 months post-baseline2
Goal Attainment Scaling
Method to establish individualized scales in order to quantify progress toward SMART personal goals.
Time frame
From baseline to 6 months post-baseline.Secondary outcomes
1
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.
Time frame
From baseline to 6 months post-baseline2
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.
Time frame
From baseline to 6 months post-baseline3
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.
Time frame
From baseline to 6 months post-baseline4
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.
Time frame
From baseline to 6 months post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Nationwide Children's Hospital
Collaborator
Source ClinicalTrials.gov