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

Cancer Clinical Trial

— Haze  

Official title:

Emerging From the Haze™-A Multi-center, Randomized Controlled Trial to Measure Impact of a Multi-dimensional Psycho-educational Program on Subjective Cognitive Complaints After Breast Cancer Treatment Using Virtual Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360917
• Other study ID #: IIT 2014-01
• Status: Completed
• Phase: N/A
• Start date: July 6, 2015
• Est. completion date: May 23, 2018

Study information

• Verified date: October 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 23, 2018
• Est. primary completion date: March 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cognition

Intervention

Other:
• Emerging from the Haze
A 6 week psycho-educational class

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	University of Kansas, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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