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

NCT02892006 | Completed

• 1 other identifier: Pro00045372
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress; Breast Neoplasms; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptoms

  Baseline to 6 weeks after baseline (t1); one month after t1

• Well Being

  Baseline to 6 weeks after baseline (t1); one month after t1

• Loneliness

  Baseline to 6 weeks after baseline (t1); one month after t1

Study Arms (1)

Intervention

EXPERIMENTAL

All participants in the study will participate a 6 week improv intervention.

Behavioral: Improvisational Comedy

Interventions

Improvisational Comedy BEHAVIORAL

6 week curriculum in improvisational comedy. Each class meets for 1.5 hours for 6 consecutive weeks.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Arash Asher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Survivorship & Rehabilitation

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 8, 2016
• Study Start: November 30, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)