Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2025-08-01
2028-09-30
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Survivors Journey Program
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.
Survivor's Journey+
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.
Internet Resources Comparison
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.
Survivor's Journey+
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.
Interventions
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Survivor's Journey+
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
25 Years
ALL
No
Sponsors
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Nationwide Children's Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Shari L Wade, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HT9425-24-1-0746
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-0546
Identifier Type: -
Identifier Source: org_study_id
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