Improv Comedy Classes for Psychological Distress After Cancer

(IMPROV2 Trial)

Recruiting at 1 trial location

Overseen By Arash Asher, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Arash Asher, MD

Disqualifiers: Personality disorders, Psychiatric disorders, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Arash Asher, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adult women over 18 who have completed breast cancer treatment (stages 1-3, no distant metastases) at least 2 months ago but not more than 18 months prior. They must be medically stable, emotionally ready for group activities, speak English, and commit to attending most improv classes.

Inclusion Criteria

I agree to fill out all required study surveys.

Emotionally stable (per physician clearance) to participate in this series.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria

Patients with severe cognitive impairments, as determined by their treating physician.

You have participated in an improvisational comedy program within the last year.

You do not speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Participants complete baseline assessments prior to randomization

2 weeks

Intervention

Participants in the intervention group complete 6 consecutive improv classes

6 weeks

Waitlist Control

Participants in the control group wait for 10 weeks before starting the improv course

10 weeks

Follow-up

Participants are monitored for well-being and other outcomes after the intervention

6 months

Treatment Details

Interventions

• Improvisational comedy classes
• Waitlist control

Trial Overview The study tests if improvisational comedy classes can help reduce psychological distress in breast cancer survivors. Participants are randomly assigned to either start improv classes right away or placed on a waitlist control group with evaluations at multiple stages.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Group II: Waitlist Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Arash Asher, MD

Lead Sponsor

Trials

6

Recruited

220+

Tower Cancer Research Foundation

Collaborator

Trials

3

Recruited

100+