Emerging From the Haze for Gynecologic Cancer Survivors

January 2, 2019 updated by: Arash Asher, MD, Cedars-Sinai Medical Center

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

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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
Time Frame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
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
Time Frame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
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
Time Frame: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
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
Time Frame: First day of class (baseline), last day of class (6 weeks)
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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