LOL: It's All Improv After Cancer!™

NCT03824132 | Completed

• 1 other identifier: IIT2018-05-ASHER-IMPROV2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall well-being

  Change of the Functional Assessment of Cancer Therapy - General (FACT-G) score between the intervention and control groups. Total scores range from 0-108, with higher scores representing better outcomes.

  6 weeks

Secondary Outcomes (6)

• Anxiety

  6 weeks

• Depression

  6 weeks

• Social Isolation

  6 weeks

• General self-efficacy

  6 weeks

• Self-efficacy for managing emotions

  6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Improvisational comedy classes

Waitlist Control Group

ACTIVE COMPARATOR

Behavioral: Waitlist control

Interventions

Improvisational comedy classes BEHAVIORAL

6 consecutive improvisational comedy classes

Intervention Group

Waitlist control BEHAVIORAL

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

Waitlist Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arash Asher, MD: lead
• Tower Cancer Research Foundation: collaborator

Study Sites (1)

Cancer Clinical Trials Office

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: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cancer Rehabilitation & Survivorship

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: August 2, 2019
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)