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LOL: It's All Improv After Cancer!™ (IMPROV2)

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ClinicalTrials.gov Identifier: NCT03824132
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Tower Cancer Research Foundation
Information provided by (Responsible Party):
Arash Asher, MD, Cedars-Sinai Medical Center

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Psychological Distress Behavioral: Improvisational comedy classes Behavioral: Waitlist control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group Behavioral: Improvisational comedy classes
6 consecutive improvisational comedy classes

Active Comparator: Waitlist Control Group Behavioral: Waitlist control
After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.




Primary Outcome Measures :
  1. Overall well-being [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 6 weeks ]
    Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Anxiety - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.

  2. Depression [ Time Frame: 6 weeks ]
    Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Depression - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.

  3. Social Isolation [ Time Frame: 6 weeks ]
    Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Social Isolation score between the intervention and control groups. Total scores range from 14-70, with lower scores representing better outcomes.

  4. General self-efficacy [ Time Frame: 6 weeks ]
    Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) General Self-Efficacy score between the intervention and control groups. Total scores range from 10-50, with higher scores representing better outcomes.

  5. Self-efficacy for managing emotions [ Time Frame: 6 weeks ]
    Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy for Managing Emotions - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with higher scores representing better outcomes.

  6. Positive psychosocial outcomes of illness [ Time Frame: 6 weeks ]
    Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Psychosocial Illness Impact - Positive - Short Form 8a score between the intervention and control groups. Total scores range from 32-80, with higher scores representing better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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 at least 4/10 (≥4) on the NCCN Distress Thermometer
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824132


Contacts
Contact: Rachel Baynes, MA 310-423-1323 Rachel.Baynes@cshs.org
Contact: Bethy Woubeshet, MPH 424-315-2215 Bethy.Woubeshet@cshs.org

Locations
United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Rachel Baynes, MA    310-423-1323    Rachel.Baynes@cshs.org   
Contact: Bethy Woubeshet, MPH    424-315-2215    Bethy.Woubeshet@cshs.org   
Principal Investigator: Arash Asher, MD         
Sponsors and Collaborators
Arash Asher, MD
Tower Cancer Research Foundation
Investigators
Principal Investigator: Arash Asher, MD Cedars-Sinai Medical Center

Responsible Party: Arash Asher, MD, Director, Cancer Rehabilitation & Survivorship, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03824132     History of Changes
Other Study ID Numbers: IIT2018-05-ASHER-IMPROV2
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No