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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-24-1-0746 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 6 months post-baseline |
| Behavior Rating Inventory of Executive Function, Second Edition-Adult Version T Scores change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shari L Wade, PhD | Contact | 513-636-3370 | shari.wade@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Shari L Wade, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
The Dept of Defense will not need to see individual participant data from our study.
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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 | 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 | 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 | 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 |
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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