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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Neoplasms; Distress
• Intervention / Treatment: Behavioral: Improvisational Comedy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; All participants in the study will participate a 6 week improv intervention.	Behavioral: Improvisational Comedy; 6 week curriculum in improvisational comedy. Each class meets for 1.5 hours for 6 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00045372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No