Emerging From the Haze for Gynecologic Cancer Survivors
Primary Purpose
Gynecologic Neoplasms, Cognition Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emerging from the Haze class
Sponsored by
About this trial
This is an interventional supportive care trial for Gynecologic Neoplasms
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.
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emerging from the Haze class
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02918461
First Posted
September 21, 2016
Last Updated
January 2, 2019
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02918461
Brief Title
Emerging From the Haze for Gynecologic Cancer Survivors
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Neoplasms, Cognition Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emerging from the Haze class
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Emerging from the Haze class
Intervention 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.
Primary Outcome Measure Information:
Title
The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey
Description
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
Time Frame
First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey
Description
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
Time Frame
First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Title
UCLA Loneliness Scale Survey
Description
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
Time Frame
First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Other Pre-specified Outcome Measures:
Title
Comparison of trainee-taught vs non-trainee taught class
Description
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
Time Frame
First day of class (baseline), last day of class (6 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Emerging From the Haze for Gynecologic Cancer Survivors
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