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临床试验/NCT02892006
NCT02892006已完成不适用

LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Feasibility

研究概览

简要总结

Managing distress and improving well-being is critically important for optimal survivorship care. Treatment of distress leads to better adherence to treatment, better communication, fewer calls and visits to the oncologist's office, and avoidance of development of severe anxiety or depression. Based on national guidelines, distress is typically managed with pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or chaplaincy services. To our knowledge, the role of a structured improvisational comedy (improv) program in reducing distress and improving well-being has never been evaluated in the oncology setting.

详细描述

With over 14 million cancer survivors today in the United States comes a unique constellation of challenges and opportunities for health care providers trying to optimize health at a time when many patients are struggling and open to learning new skills for strengthening their own resiliency and ability to cope. Not only does a significant subset of patients with cancer experience an increase in negative emotions, such as distress, anxiety and depression, but they often also experience a lack of positive emotions (Hart 2010). Managing distress and improving well-being is critically important for optimal survivorship care. Treatment of distress leads to better adherence to treatment, better communication, fewer calls and visits to the oncologist's office, and avoidance of development of severe anxiety or depression (Partridge, Wang et al. 2003; Carlson and Bultz 2004; 2014). Based on national guidelines, distress is typically managed with pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or chaplaincy services. To our knowledge, the role of a structured improvisational comedy (improv) program in reducing distress and improving well-being has never been evaluated in the oncology setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Female, diagnosed with breast cancer stage 1-3 (no distant metastases)
  • Completed cancer treatment (including chemotherapy, radiation therapy, biologic treatment, and/or any combination) at least 1 month (30 days) from their last treatment and no more than 12 months (365 days) post-treatment. Long term hormonal/biologic treatments are ok.
  • Female age ≥ 18
  • Scores a at least 4/10 (≥4) on the National Comprehensive Cancer Network Distress Thermometer
  • Agrees to complete study surveys
  • Agrees to attend 6 improv classes
  • English speaking
  • Emotionally stable (per physician clearance) to participate in this series

排除标准

  • 未提供

结局指标

主要结局

Feasibility

时间窗: Baseline to 6 weeks after baseline

We will define feasibility by our attrition rate. We will assess the rate of accrual and the number of patients who complete the intervention

次要结局

  • Well Being(Baseline to 6 weeks after baseline (t1); one month after t1)
  • Loneliness(Baseline to 6 weeks after baseline (t1); one month after t1)
  • Symptoms(Baseline to 6 weeks after baseline (t1); one month after t1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arash Asher, MD

Director, Cancer Survivorship & Rehabilitation

Cedars-Sinai Medical Center

研究点 (2)

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