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

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.

Study Overview

• Status: Completed
• Conditions: Cognition Disorders; Gynecologic Neoplasms
• Intervention / Treatment: Behavioral: Emerging from the Haze class

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emerging from the Haze class; 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.	Behavioral: Emerging from the Haze class; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey	Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class	First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey	Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class	First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
UCLA Loneliness Scale Survey	Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class	First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of trainee-taught vs non-trainee taught class	To compare the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self report of cognitive changes based on change of the FACT-Cog compared to the impact of an ongoing non-trainee-taught Emerging from the Haze course on breast cancer survivors' self report of cognitive changes based on the change in FACT-Cog score from first day of class (baseline) to last day of class (6 weeks) in these two groups	First day of class (baseline), last day of class (6 weeks)

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Cognition Disorders; Genital Neoplasms, Female
• Other Study ID Numbers: Pro00046105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No