Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment brain fitness program (bfp)
Sponsor New York University School of Medicine
Start date September 2013
End date August 2016
Trial size 24 participants
Trial identifier NCT02515487, 13-00146

Summary

The main goal of this project is to identify and remediate the cognitive difficulties, including processing speed and attention deficits in individuals who have undergone chemotherapy treatment. Recent research has demonstrated objective cognitive deficits following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it was once considered. There are a large number of woman diagnosed and treated for breast cancer that experience chemotherapy induced cognitive deficits.

Subjects who participate in the study will be evaluated for cognitive abilities prior to chemotherapy treatment and after completion of chemotherapy. Participants will then have the option to participate in the second phase of the study, which involves the use of a computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive evaluation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
brain fitness program (bfp)
The program is designed to improve processing speed of auditory information and attention. The BFP is comprised of six computerized subtests that continuously adjust in the level of difficulty to maintain an 85% correct response rate. The subtest exercises include discrimination of confusable syllables, recognition of sequences of syllables, matching pairs of confusable syllables, reconstruction of sequences of verbal instructions and identification of details in a verbally presented story. Participants will participate in 40 one-hour training sessions over a 12 week period to complete all cognitive remediation training sessions. Since this intervention is presented both visually and verbally, noise cancelling headphones will be provided to the participants.

Primary Outcomes

Measure
Change in Wechsler Test of Adult Reading (WTAR)
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Processing Speed (PS)
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Executive Functions
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Working Memory and Attention
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Visual and Verbal Memory
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Depression
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Anxiety
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Frontal Systems Behavior Scale (FRSBE)
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Cognitive Self-Report Questionnaire (CSRQ)
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog)
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-F)
time frame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. Diagnosis of breast cancer with adjuvant chemotherapy treatment 2. all subjects will be between the ages of 18 and 70 years old 3. free from significant psychiatric history 4. free of current alcohol or drug abuse. 5. All participants need to understand and read English and have the capacity to consent. Exclusion Criteria: 1. Individuals with pre-exiting neurological disorder (i.e. brain tumors, dementia, Parkinson's disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer. 2. Individuals younger than 18 years old and older than 70 years old will also be excluded due to developmental changes that occur in those years. 3. Individuals with a current substance use disorder will also be excluded. 4. Individuals who lack the capacity to consent will be excluded from this study.

Additional Information

Official title An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer
Principal investigator Gerald Voelbel, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.