Emerging From the Haze for Gynecologic Cancer Survivors

Completed · Not applicable

Conditions studied: Gynecologic Neoplasms, Cognition Disorders

In brief

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.

Key facts

Study ID

NCT02918461

Run by

Cedars-Sinai Medical Center

People needed

11

Starts

2017-01-10

Expected to finish

2017-11-01

Last updated by the study team

2019-01-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.