A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Feasibility of Intervention
研究概览
简要总结
The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.
详细描述
Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)
- •Either: (1) Indicates a score ≥4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score ≥4 on the NCCN adapted distress thermometer study screening questions
- •English-speaking
排除标准
- •Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
研究组 & 干预措施
Young Adults Coping with Cancer Together Intervention
Young adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks.
干预措施: Young Adults Coping with Cancer Together Intervention (Behavioral)
结局指标
主要结局
Feasibility of Intervention
时间窗: 14 +/- 2 Weeks
Feasibility will be measured by measured by participant rates of enrollment (≥50% of those eligible), participant retention (≥70% of those enrolled), and intervention attendance (≥70% attending at least 6 of 8 sessions).
Acceptability of Intervention
时间窗: 14 +/- 2 Weeks
Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥75% of participants report average satisfaction that exceeds the CSQ's midpoint.
次要结局
未报告次要终点
研究者
Jamie Jacobs
Assistant Professor, Harvard Medical School Department of Psychiatry
Massachusetts General Hospital