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Completed

NCT Number: NCT02360917

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emerging from the Haze

Other

A 6 week psycho-educational class

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • University of Kansas
  • University of Pittsburgh

Registry information

Official study 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

Acronym: Haze

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2015
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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