LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer
Primary Purpose
Distress, Breast Neoplasms, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Improvisational Comedy
Sponsored by
About this trial
This is an interventional other trial for Distress
Eligibility Criteria
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
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
All participants in the study will participate a 6 week improv intervention.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Symptoms
We will assess the impact of a 6-week improv program on patient reported symptoms using the PROMIS-29 scale.
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.
Loneliness
We will assess the impact of a 6-week improv program on loneliness. Loneliness will be assessed using the UCLA Loneliness Scale.
Full Information
NCT ID
NCT02892006
First Posted
August 11, 2016
Last Updated
September 5, 2018
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02892006
Brief Title
LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer
Official Title
LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Breast Neoplasms, Quality of Life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All participants in the study will participate a 6 week improv intervention.
Intervention Type
Behavioral
Intervention Name(s)
Improvisational Comedy
Intervention Description
6 week curriculum in improvisational comedy. Each class meets for 1.5 hours for 6 consecutive weeks.
Primary Outcome Measure Information:
Title
Feasibility
Description
We will define feasibility by our attrition rate. We will assess the rate of accrual and the number of patients who complete the intervention
Time Frame
Baseline to 6 weeks after baseline
Secondary Outcome Measure Information:
Title
Symptoms
Description
We will assess the impact of a 6-week improv program on patient reported symptoms using the PROMIS-29 scale.
Time Frame
Baseline to 6 weeks after baseline (t1); one month after t1
Title
Well Being
Description
We will assess the impact of a 6-week improv program on well being. Well-being will be assessed using the FACT-G scale.
Time Frame
Baseline to 6 weeks after baseline (t1); one month after t1
Title
Loneliness
Description
We will assess the impact of a 6-week improv program on loneliness. Loneliness will be assessed using the UCLA Loneliness Scale.
Time Frame
Baseline to 6 weeks after baseline (t1); one month after t1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer
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