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

NCT02360917 | Completed

• 1 other identifier: IIT 2014-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Cancer

Keywords

Cognitive Dysfunction; Cancer Survivorship

Outcome Measures

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.

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Waitlist

OTHER

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

Emerging from the Haze OTHER

A 6 week psycho-educational class

Intervention; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of Kansas: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jamie Myers, PhD, RN AOCNSP

  University of Kansas

  PRINCIPAL INVESTIGATOR

• Arash Asher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Survivorship and Rehabilitation Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai Medical Center

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: July 6, 2015
• Primary Completion: March 17, 2018
• Study Completion: May 23, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

US (1)