Online Problem-Solving Intervention for Brain Tumor Survivors: A Two-site, Two-arm Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life Inventory Total Scale Score change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Survivor's Journey+ (Behavioral)
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.
干预措施: Survivor's Journey+ (Behavioral)
结局指标
主要结局
Pediatric Quality of Life Inventory Total Scale Score change
时间窗: 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
时间窗: From baseline to 6 months post-baseline.
Method to establish individualized scales in order to quantify progress toward SMART personal goals.
次要结局
- Behavior Rating Inventory of Executive Function, Second Edition T Scores change(From baseline to 6 months post-baseline)
- Behavior Rating Inventory of Executive Function, Second Edition-Adult Version T Scores change(From baseline to 6 months post-baseline)
- Patient-Reported Outcomes Measurement Information System change(From baseline to 6 months post-baseline)
- Hospital Anxiety and Depression Scale change(From baseline to 6 months post-baseline)
- Strength & Difficulties Questionnaire change(From baseline to 6 months post-baseline)