Clinical trial NCT02892006: 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
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Breast Neoplasms
Quality of Life
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: Baseline to 6 weeks after baseline
Secondary outcomes:
measure: Symptoms
timeFrame: Baseline to 6 weeks after baseline (t1); one month after t1
measure: Well Being
timeFrame: Baseline to 6 weeks after baseline (t1); one month after t1
measure: Loneliness
timeFrame: Baseline to 6 weeks after baseline (t1); one month after t1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: