Cognition Disorders, Gynecologic Neoplasms
Conditions
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.
Interventions
BEHAVIORALEmerging 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed