An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors

NCT ID: NCT02515487

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2018-01-31

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Breast cancer patients receiving chemotherapy treatment

Group Type: EXPERIMENTAL

Brain Fitness Program (BFP)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald Voelbel, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

NYU Perlmutter Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

13-00146

Identifier Type: -

Identifier Source: org_study_id