The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
研究概览
简要总结
The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to:
- Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback.
- Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care.
Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.
详细描述
In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12-25 years
- •Diagnosed with new malignancy treated with chemotherapy and/or radiation <6-months
- •Able to speak in the English language
- •Able to read in the English language
- •Cognitively able to participate in intervention sessions and complete surveys
排除标准
- •Aged <12 or >25 years
- •Diagnosed with recurrent malignancy
- •Diagnosed with new malignancy >6 months
- •Not receiving chemotherapy and/or radiation
- •Not able to speak in the English language
- •Not able to read in the English language
- •Not cognitively able to participate in intervention session or complete surveys
研究组 & 干预措施
PRISM-SN Intervention
Skill-based psychosocial program
干预措施: Promoting Resilience in Stress Management - Social Needs (PRISM-SN) (Behavioral)
Usual Care
Standard psychosocial care
结局指标
主要结局
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
时间窗: 12-weeks
The Cancer Behavior Inventory - Social Relationship Coping Efficacy measure assesses one's confidence to engage in behaviors that maintain or enhance close social relationships in the context of illness. Ten items are rated 1-10; items are summed, with higher scores reflecting higher social relationship coping efficacy.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(12-weeks)
- Snyder Hope Scale(12-weeks)
- Multidimensional Scale of Perceived Social Support (MSPSS)(12-weeks)
- Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale(12-weeks)
- Connor-Davidson Resilience Scale (CS-RISC)(12-weeks)
研究者
Kaitlyn Fladeboe
Principal Investigator
Seattle Children's Hospital