Emerging From the Haze for Gynecologic Cancer Survivors

Cedars-Sinai Medical Center

Status: Completed

Conditions: Cognition Disorders; Gynecologic Neoplasms

Treatments: Behavioral: Emerging from the Haze class

Study type: Interventional

Funder types: Other

Identifiers

NCT02918461

Pro00046105

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Emerging from the Haze class

Experimental group

Description:

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.

Treatment:

Behavioral: Emerging from the Haze class