Emerging From the Haze for Gynecologic Cancer Survivors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Emerging from the Haze class 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
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.
|
Outcome Measures
Primary Outcome Measures
- The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey [First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class]
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
Secondary Outcome Measures
- Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey [First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class]
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
- UCLA Loneliness Scale Survey [First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class]
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
Other Outcome Measures
- Comparison of trainee-taught vs non-trainee taught class [First day of class (baseline), last day of class (6 weeks)]
To compare the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self report of cognitive changes based on change of the FACT-Cog compared to the impact of an ongoing non-trainee-taught Emerging from the Haze course on breast cancer survivors' self report of cognitive changes based on the change in FACT-Cog score from first day of class (baseline) to last day of class (6 weeks) in these two groups
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of any stage gynecologic cancer including ovarian, uterine/endometrial, cervical, vulvar, and vaginal cancer
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Treated with chemotherapy solely or in combination with surgery, radiation, and/or hormonal therapy
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Female, age ≥ 18 years.
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FACT-Cog score < 59 on the PCI sub scale
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Eligible after 2 months (60 ±5 days) of completing all their active cancer treatment with the exception of long-term hormonal treatments
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Subjective complaint of cognitive concerns at time of enrollment
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Must be able to understand and communicate proficiently in English
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Ability to understand and the willingness to sign a written informed consent.
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Agree to complete study surveys
Exclusion Criteria:
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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
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Patients with known brain metastases, history of brain metastases or radiation to the brain.
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Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
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Non-English speakers
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Receiving treatment for another malignancy other than breast cancer
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
- Principal Investigator: Arash Asher, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00046105