Clinical trial NCT02360917: Emerging From the Haze™- Measuring the Impact of a Psycho-education Program on Perceived Cognition After Breast Cancer Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Cancer
Keywords: Cognitive Dysfunction
Cancer Survivorship
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: University of Pittsburgh
First posted: 2015-02-11
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: University of Kansas
name: Jamie Myers, PhD, RN AOCNSP
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: