CompletedNCT02360917HazeUpdated Nov 1, 2018

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

An interventional study of Emerging from the Haze in Cognition and Cancer, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 31
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Conditions studied

Cognition
Cancer

Keywords

Cognitive Dysfunction
Cancer Survivorship

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts 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

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

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 31 participants (actual)

Study arms

Experimental
Intervention
Participants in the intervention group will undergo 6 weeks of psycho-educational classes provided in a live setting at Cedars Sinai and a web based setting at The University of Kansas. Each class will focus on a different realm of coping with chemo-brain.
Other: Emerging from the Haze
Other
Waitlist
Participants assigned to the control group will be placed on a wait list for the Haze program. While they are waiting for admittance to the program, they will receive the same surveys as the participants who are taking the Haze class. Additionally, participants assigned to the control group will receive the surveys again when taking the class in order to allow comparison of the effects of the program on the control group. Participants assigned to the wait list will be enrolled in the following Haze series.
Other: Emerging from the Haze

Interventions

OtherEmerging from the Haze
A 6 week psycho-educational class

What researchers measure

Primary outcomes

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.
Time frame: 6 weeks

Study locations

1 site

Cedars Sinai Medical Center
Los Angeles, California 90048, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02360917
Lead sponsor: Cedars-Sinai Medical Center
Collaborators: University of Kansas, University of Pittsburgh
Responsible party: Arash Asher, MD (Director, Cancer Survivorship and Rehabilitation Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai Medical Center, Cedars-Sinai Medical Center) — Principal investigator
First posted: Feb 11, 2015
Start date: Jul 6, 2015
Primary completion: Mar 17, 2018
Completion: May 23, 2018
Last update: Nov 1, 2018

Study contacts

Jamie Myers, PhD, RN AOCNSP

principal investigator · University of Kansas

Arash Asher, MD

principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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