Emerging From the Haze for Gynecologic Cancer Survivors

Cognition Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918461
• Other study ID #: Pro00046105
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: November 2017

Study information

• Verified date: January 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Genital Neoplasms, Female
• Gynecologic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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
Secondary	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