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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02360917
Acronym
Haze
Enrollment
31
Registered
2015-02-11
Start date
2015-07-06
Completion date
2018-05-23
Last updated
2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cognition

Keywords

Cognitive Dysfunction, Cancer Survivorship

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.

Interventions

OTHEREmerging from the Haze

A 6 week psycho-educational class

Sponsors

University of Kansas
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026