A Randomized Controlled Trial to Strengthen Existential Resiliency Among Women With Metastatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- GRACE's Impact on Existential Distress (measured by survey)
研究概览
简要总结
The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving psycho-education and process-oriented experiences. The curriculum includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with metastatic cancer with a minimum prognosis of 3 months
- •Existential or spiritual concerns
- •Reasonable medical stability as assessed by the evaluating physician
- •Commits to attending 5/6 of the GRACE classes
- •English speaking
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Unstable psychiatric disorder that would detract from a group program (i.e. severe depression/anxiety not controlled medically, volatile personality disorders)
- •Cognitive impairment or cognitive linguistic impairment (i.e., aphasia) that would interfere with a group program.
研究组 & 干预措施
Intervention Arm
Patients in the intervention group will be provided with all programmatic materials (including copies of power point presentations, copies of reading texts, and audio CDs) and classes will be held in group format, with a maximum of 9 participants per group. Classes will meet weekly, in a group, and at a set time. All classes will be facilitated jointly by the two Co-PIs. All participants will complete surveys before class, during class, at the end of class, 1 month after the end of class, 6 months after the end of class and 1 year after the end of the class. Additionally, those randomized to the intervention group will be asked to attend a 1 time focus group 1 week after the end of the class.
干预措施: Growing Resiliency And CouragE with Cancer™ (GRACE) (Other)
Control Arm
Patients in the control group will be asked to complete surveys at: baseline, 6 weeks after baseline (T1), and 1 month after T1. After T1, the control group will off study and will be permitted to attend the next available GRACE course.
结局指标
主要结局
GRACE's Impact on Existential Distress (measured by survey)
时间窗: Baseline to 6 weeks after baseline
次要结局
- GRACE's Impact on anxiety (measured by survey)(Baseline to 10 weeks after baseline)
- GRACE's Impact on depression (measured by survey)(Baseline to 10 weeks after baseline)
- GRACE's Impact on hopelessness (measured by survey)(Baseline to 10 weeks after baseline)
- GRACE's Impact on loneliness (measured by survey)(Baseline to 10 weeks after baseline)
- GRACE's Impact on Existential Distress (measured by survey)(Baseline to 10 weeks after baseline)
- GRACE's Impact on anxiety (measured by survey)(Baseline to 6 weeks after baseline)
- GRACE's Impact on depression (measured by survey)(Baseline to 6 weeks after baseline)
- GRACE's Impact on hopelessness (measured by survey)(Baseline to 6 weeks after baseline)
- GRACE's Impact on loneliness (measured by survey)(Baseline to 6 weeks after baseline)
研究者
Arash Asher, MD
Director, Cancer Survivorship & Rehabilitation
Cedars-Sinai Medical Center