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Completed

NCT Number: NCT02892006

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Improvisational Comedy

Behavioral

6 week curriculum in improvisational comedy. Each class meets for 1.5 hours for 6 consecutive weeks.

Primary outcomes

  1. Feasibility

    Time frame: 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

Secondary outcomes

  1. Symptoms

    Time frame: Baseline to 6 weeks after baseline (t1); one month after t1

    We will assess the impact of a 6-week improv program on patient reported symptoms using the PROMIS-29 scale.

  2. Well Being

    Time frame: Baseline to 6 weeks after baseline (t1); one month after t1

    We will assess the impact of a 6-week improv program on well being. Well-being will be assessed using the FACT-G scale.

  3. Loneliness

    Time frame: Baseline to 6 weeks after baseline (t1); one month after t1

    We will assess the impact of a 6-week improv program on loneliness. Loneliness will be assessed using the UCLA Loneliness Scale.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2016
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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