Emerging From the Haze for Gynecologic Cancer Survivors

Study Overview
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Brief Summary
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At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks. The objective of this study is to quantify the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the change of FACT-Cog score.

Official Title
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A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors

Conditions
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Gynecologic Neoplasms, Cognition Disorders

Intervention / Treatment
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* Behavioral: Emerging from the Haze class


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of any stage gynecologic cancer including ovarian, uterine/endometrial, cervical, vulvar, and vaginal cancer Treated with chemotherapy solely or in combination with surgery, radiation, and/or hormonal therapy Female, age ≥ 18 years. FACT-Cog score < 59 on the PCI sub scale Eligible after 2 months (60 ±5 days) of completing all their active cancer treatment with the exception of long-term hormonal treatments Subjective complaint of cognitive concerns at time of enrollment Must be able to understand and communicate proficiently in English Ability to understand and the willingness to sign a written informed consent. Agree to complete study surveys Exclusion Criteria: Patients who have significant personality disorders or unstable psychiatric disorders (including active major depression, substance abuse, psychosis or bipolar disorder) as assessed by the interviewing clinician Patients with known brain metastases, history of brain metastases or radiation to the brain. Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction. Non-English speakers Receiving treatment for another malignancy other than breast cancer Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, chronic anemia, uncontrolled hypothyroidism, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emerging from the Haze class<br>A 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks. | Behavioral: Emerging from the Haze class<br>* A 6-week class designed to combat chemotherapy-induced cognitive dysfunction. Patients will report symptoms at 6 months and 1 year after the end of their Haze class.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey | Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class | First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey | Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class | First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class | 
| UCLA Loneliness Scale Survey | Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class | First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class |