IIT2018-05-ASHER-IMPROV2 - LOL: It's All Improv After Cancer!™ - a Randomized Clinical Trial Examining the Impact of an Improvisational Comedy Intervention on Well-Being Among Patients with Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Overall well-being
研究概览
简要总结
This is a 2-arm randomized waitlist controlled trial. A total of 46 of subjects are planned. Subjects will be assigned to the intervention vs. waitlist control group in a randomized fashion. All subjects will complete baseline assessments prior to randomization. Baseline assessments will be completed within two weeks before the start of the improv series. Subjects in the intervention group will complete 6 consecutive improv classes. Patients in the control group will be permitted to complete the improv course (within 10-12 weeks) and follow-up after their 10 week control timeline is complete. Evaluations for the intervention group will be taken at baseline (T0), the last day of class (T1), one month after the last day of class (T2), and 6 months after the last day of class (T3). Evaluations for the waitlist control group will be taken at baseline #1 (T0), 6 weeks after T0 (T1), one month after T1 (T2), first day of class (Baseline 2, T0b), last day of class (T1b), one month after the last day of class (T2b), and 6 months after the last day of class (T3b). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of the study is expected to be 2 years.
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
- •Diagnosed with breast cancer stage 1-3 (no distant metastases)
- •Completed cancer treatment (including chemotherapy, radiation therapy, biologic treatment, and/or any combination). At time of consent, patient must be at least 2 months (60 days) from their last treatment and no more than 18 months (547 days) post-treatment. Long term hormonal/biologic treatments are ok.
- •Adult female age ≥18
- •Scores ≤82 on the FACT-G (Patients do not need to maintain score ≤82 after initial screening FACT-G to remain on study)
- •Agrees to complete study surveys
- •Agrees to attend at least 4 of 6 Improv classes
- •English speaking
- •Reasonable medical stability (per physician clearance).
- •Emotionally stable (per physician clearance) to participate in this series.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Patients who have significant personality disorders or unstable psychiatric disorders that are severe enough to detract from the group process, as determined by their treating physician.
- •Patients with severe cognitive impairments, as determined by their treating physician.
- •Non-English speakers.
- •Patients who have previously participated in an improvisational comedy program in the past year.
结局指标
主要结局
Overall well-being
时间窗: 6 weeks
Change of the Functional Assessment of Cancer Therapy - General (FACT-G) score between the intervention and control groups. Total scores range from 0-108, with higher scores representing better outcomes.
次要结局
- General self-efficacy(6 weeks)
- Self-efficacy for managing emotions(6 weeks)
- Anxiety(6 weeks)
- Depression(6 weeks)
- Social Isolation(6 weeks)
- Positive psychosocial outcomes of illness(6 weeks)
研究者
Arash Asher, MD
Director, Cancer Rehabilitation & Survivorship
Cedars-Sinai Medical Center