Emerging From the Haze for Gynecologic Cancer Survivors

NCT02918461 | Completed

• 1 other identifier: Pro00046105
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Neoplasms; Cognition Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey

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

• UCLA Loneliness Scale Survey

  First day of class (baseline), 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

  First day of class (baseline), last day of class (6 weeks)

Study Arms (1)

Emerging from the Haze class

EXPERIMENTAL

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

Interventions

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.

Emerging from the Haze class

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Genital Neoplasms, Female; Cognition Disorders

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Arash Asher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Rehabilitation and Survivorship

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 29, 2016
• Study Start: January 10, 2017
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)