Breast Cancer Clinical Trial

Emerging From the Haze for Gynecologic Cancer Survivors

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 Hazeâ„¢ (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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

11

Study ID:

NCT02918461

Recruitment Status:

Completed

Sponsor:

Cedars-Sinai Medical Center

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There is 1 Location for this study

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Cedars Sinai Medical Center
Los Angeles California, 90048, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

11

Study ID:

NCT02918461

Recruitment Status:

Completed

Sponsor:


Cedars-Sinai Medical Center

How clear is this clinincal trial information?

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