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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
13
6 consecutive improvisational comedy classes
After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.
Cancer Clinical Trials Office
Los Angeles, California, United States
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.
Time frame: 6 weeks
Anxiety
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.
Time frame: 6 weeks
Depression
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.
Time frame: 6 weeks
Social Isolation
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.
Time frame: 6 weeks
General self-efficacy
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.
Time frame: 6 weeks
Self-efficacy for managing emotions
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.
Time frame: 6 weeks
Positive psychosocial outcomes of illness
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.
Time frame: 6 weeks
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