Clinical trial NCT02918461: Emerging From the Haze for Gynecologic Cancer Survivors
Official title: A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Neoplasms
Cognition Disorders
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey
timeFrame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey
timeFrame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
measure: UCLA Loneliness Scale Survey
timeFrame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Other outcomes:
measure: Comparison of trainee-taught vs non-trainee taught class
timeFrame: First day of class (baseline), last day of class (6 weeks)
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: