LOL: It's All Improv After Cancer!™
NCT03824132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-03-05
Summary
This is a 2-arm randomized waitlist controlled trial. A total of 46 of subjects are planned. Subjects will be assigned to the intervention vs. waitlist control group in a randomized fashion. All subjects will complete baseline assessments prior to randomization. Baseline assessments will be completed within two weeks before the start of the improv series. Subjects in the intervention group will complete 6 consecutive improv classes. Patients in the control group will be permitted to complete the improv course (within 10-12 weeks) and follow-up after their 10 week control timeline is complete. Evaluations for the intervention group will be taken at baseline (T0), the last day of class (T1), one month after the last day of class (T2), and 6 months after the last day of class (T3). Evaluations for the waitlist control group will be taken at baseline #1 (T0), 6 weeks after T0 (T1), one month after T1 (T2), first day of class (Baseline 2, T0b), last day of class (T1b), one month after the last day of class (T2b), and 6 months after the last day of class (T3b). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of the study is expected to be 2 years.
Conditions
- Breast Cancer
- Psychological Distress
Interventions
- BEHAVIORAL
-
Improvisational comedy classes
6 consecutive improvisational comedy classes
- BEHAVIORAL
-
Waitlist control
After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.
Sponsors & Collaborators
-
Tower Cancer Research Foundation
collaborator UNKNOWN -
Arash Asher, MD
lead OTHER
Principal Investigators
-
Arash Asher, MD · Cedars-Sinai Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-02
- Primary Completion
- 2024-07-19
- Completion
- 2024-07-19
Countries
- United States
Study Locations
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