Emerging From the Haze™- Measuring the Impact of a Psycho-education Program on Perceived Cognition After Breast Cancer Treatment

Not Applicable

Completed

• Conditions: Cognition; Cancer

• Registration Number: NCT02360917
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

At Cedars-Sinai Medical Center, we 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 hours for 6 weeks. The leading neuropsychologist covers material such as guided relaxation, behavioral strategies for automatic/negative thoughts, compensatory strategies for attention and memory, executive functioning, pacing, and balance. Each Haze series will be electronically delivered in a live format to our satellite site, The University of Kansas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-11
• Study Start: 2015-07-06
• Primary Completion: 2018-03-17
• Study Completion: 2018-05-23
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• Completed treatment for stage 1-3 breast cancer at least two months but not more than 24 months prior to enrollment.
• Having received chemotherapy with or without radiation therapy
• Female, Age ≥18 years.
• FACT-Cog score less than 59 on the Perceived Cognitive Impairment subscale
• Eligible after 2 months of completing all their active cancer treatment with the exception of long-term hormonal treatments or trastuzumab.
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
quantify the impact of Emerging from the Haze on breast cancer survivors' self-report of cognitive changes, based on change of the FACT-Cog- perceived cognitive impairment score from baseline to the end of the Haze series compared to the control group.	6 weeks

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States