LOL: It's All Improv After Cancer!™

NCT ID: NCT03824132

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-02
• Study Completion Date: 2024-07-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Group Type: EXPERIMENTAL

Improvisational comedy classes

Intervention Type: BEHAVIORAL

6 consecutive improvisational comedy classes

Waitlist Control Group

Group Type: ACTIVE_COMPARATOR

Waitlist control

Intervention Type: BEHAVIORAL

After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.

Interventions

Improvisational comedy classes

6 consecutive improvisational comedy classes

Intervention Type: BEHAVIORAL

Waitlist control

After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with breast cancer stage 1-3 (no distant metastases)
• Completed cancer treatment (including chemotherapy, radiation therapy, biologic treatment, and/or any combination). At time of consent, patient must be at least 2 months (60 days) from their last treatment and no more than 18 months (547 days) post-treatment. Long term hormonal/biologic treatments are ok.
• Adult female age ≥18
• Scores ≤82 on the FACT-G (Patients do not need to maintain score ≤82 after initial screening FACT-G to remain on study)
• Agrees to complete study surveys
• Agrees to attend at least 4 of 6 Improv classes
• English speaking
• Reasonable medical stability (per physician clearance).
• 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 who have significant personality disorders or unstable psychiatric disorders that are severe enough to detract from the group process, as determined by their treating physician.
• Patients with severe cognitive impairments, as determined by their treating physician.
• Non-English speakers.
• Patients who have previously participated in an improvisational comedy program in the past year.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tower Cancer Research Foundation

UNKNOWN

Sponsor Role: collaborator

Arash Asher, MD

OTHER

Sponsor Role: lead

Responsible Party

Arash Asher, MD

Director, Cancer Rehabilitation & Survivorship

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arash Asher, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cancer Clinical Trials Office

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2018-05-ASHER-IMPROV2

Identifier Type: -

Identifier Source: org_study_id