Skip to main content
OpenTrials
Completed

NCT Number: NCT02918461

Emerging From the Haze for 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emerging from the Haze class

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2016
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.