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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892006
• Other study ID #: Pro00045372
• Status: Completed
• Phase: N/A
• Start date: November 30, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: September 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Distress
• Quality of Life

Intervention

Behavioral:
• Improvisational Comedy
6 week curriculum in improvisational comedy. Each class meets for 1.5 hours for 6 consecutive weeks.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	We will define feasibility by our attrition rate. We will assess the rate of accrual and the number of patients who complete the intervention	Baseline to 6 weeks after baseline
Secondary	Symptoms	We will assess the impact of a 6-week improv program on patient reported symptoms using the PROMIS-29 scale.	Baseline to 6 weeks after baseline (t1); one month after t1
Secondary	Well Being	We will assess the impact of a 6-week improv program on well being. Well-being will be assessed using the FACT-G scale.	Baseline to 6 weeks after baseline (t1); one month after t1
Secondary	Loneliness	We will assess the impact of a 6-week improv program on loneliness. Loneliness will be assessed using the UCLA Loneliness Scale.	Baseline to 6 weeks after baseline (t1); one month after t1