NCT03824132

LOL: It's All Improv After Cancer!™

IIT2018-05-ASHER-IMPROV2 - LOL: It's All Improv After Cancer!™ - A Randomized Clinical Trial Examining the Impact of an Improvisational Comedy Intervention on Well-Being Among Patients With Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Arash Asher, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-08-02
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2019-01-31
• Last updated: 2025-03-05

Locations

1 site across 1 country: United States