Emerging From the Haze for Gynecologic Cancer Survivors
- Conditions
- Cognition DisordersGynecologic Neoplasms
- Interventions
- Behavioral: Emerging from the Haze class
- Registration Number
- NCT02918461
- Lead Sponsor
- Cedars-Sinai Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 11
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Emerging from the Haze class 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States