Emerging From the Haze for Gynecologic Cancer Survivors

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

Sponsors

Lead Sponsor: Cedars-Sinai Medical Center

Source 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.

Overall Status Completed
Start Date 2017-01-10
Completion Date 2017-11-01
Primary Completion Date 2017-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
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
UCLA Loneliness Scale Survey First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Enrollment 11
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Emerging from the Haze class

Description: A 6-week class designed to combat chemotherapy-induced cognitive dysfunction. Patients will report symptoms at 6 months and 1 year after the end of their Haze class.

Arm Group Label: Emerging from the Haze class

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.

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Arash Asher, MD Principal Investigator Cedars-Sinai Medical Center
Location
Facility: Cedars Sinai Medical Center
Location Countries

United States

Verification Date

2019-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cedars-Sinai Medical Center

Investigator Full Name: Arash Asher, MD

Investigator Title: Director of Cancer Rehabilitation and Survivorship

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Emerging from the Haze class

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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