LOL: It's All Improv After Cancer!™
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | March 2019 |
| End Date: | July 2021 |
| Contact: | Rachel Baynes, MA |
| Email: | Rachel.Baynes@cshs.org |
| Phone: | 310-423-1323 |
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
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.
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.
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.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Arash Asher, MD
Phone: 310-423-1323
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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