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

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02892006
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
12.6
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Improvisational Comedy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer
Actual Study Start Date :
Nov 30, 2016
Actual Primary Completion Date :
Dec 20, 2017
Actual Study Completion Date :
Dec 20, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility [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 Outcome Measures

  1. Symptoms [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars Sinai Medical Center Los Angeles California United States 90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Arash Asher, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arash Asher, MD, Director, Cancer Survivorship & Rehabilitation, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02892006
Other Study ID Numbers:
  • Pro00045372
First Posted:
Sep 8, 2016
Last Update Posted:
Sep 7, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Sep 7, 2018