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An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brain Fitness Program (BFP)

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Post-chemotherapy, cognitive impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of breast cancer with adjuvant chemotherapy treatment
all subjects will be between the ages of 18 and 70 years old
free from significant psychiatric history
free of current alcohol or drug abuse.
All participants need to understand and read English and have the capacity to consent.

Exclusion Criteria:

Individuals with pre-exiting neurological disorder (i.e. brain tumors, dementia, Parkinson's disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer.
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.
Individuals with a current substance use disorder will also be excluded.
Individuals who lack the capacity to consent will be excluded from this study.

Sites / Locations

NYU Perlmutter Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast cancer patients receiving chemotherapy treatment

Arm Description

Outcomes

Primary Outcome Measures

Change in Wechsler Test of Adult Reading (WTAR)

The WTAR is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.

Change in Processing Speed (PS)

1) The Paced Auditory Serial Addition Test (PASAT), which assesses complex mental manipulation of verbally presented single digit numbers. The task requires the participant to mentally add and verbally express the last two numbers presented. There are 60 trials in each of the two sets of numbers that are presented at two different speeds; 2) Symbol-Digit Modality Test requires that the subject copies numbers that are paired with symbols within a specified time limit. The coding subtest involves processing speed, short term visual memory, psychomotor speed, visual perception and visual scanning ability. 3) The Stroop Test has three parts to it: the first task requires the participant to respond to every word as quickly as possible that is presented on the computer screen. The second task requires a response when the color word matches the meaning of the word. The third task requires a response when the color of the word does not match the meaning of the word.

Change in Executive Functions

The Trail Making Test, Part A & B: are measures of visual search efficiency and set shifting while alternating between letters and numbers. Additionally, the Verbal Fluency subtest of the Delis-Kaplan Executive Functioning Scale (D-KEFS) will be used to measure semantic and phonemic fluency through a task of word naming, where subjects are asked to list as many words as they can within 60-second time limit that begin with a specific letter (i.e., F, A, and S), and a task of category naming, where subjects are asked to list as many words as they can within 60-second time limit that fall within a specified category (i.e., animals and boy's names), respectfully. This subtest also measures category switching ability via a task where subjects are asked to list as many words as they can within 60-second time that fall within two alternating categories (i.e., fruits/furniture).

Change in Working Memory and Attention

1) Digit-Span Task, this is a standardized measure of verbal working memory in which participants recall a string of numbers that are verbally presented. 2) The Continuous Performance subtest of the CNS Vital Signs neurocognitive battery. The Continuous Performance test assesses sustained attention and reaction time to targets presented on the computer by requiring the participant to respond only when a specific designated letter is presented during a 5 minute trial. 3) The Shifting Attention subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess the participant's ability to maintain attention while switching between sets of target. 4) Four-Parts Continuous performance subtest of the CNS Vital Signs neurocognitive battery, which is a measure of working memory and sustained attention.

Change in Visual and Verbal Memory

Verbal memory will be assessed with the California Verbal Learning Test (CVLT-II) which assesses learning and rote memory of verbal material. Subjects are verbally presented with a list of words that are assessed immediately and after a 20-minute delay with and without cues. The short form version of this test will be used. The Visual Memory subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess non-verbal memory of immediate and delayed recall.

Change in Depression

Beck Depression Inventory -II: This is a standardized instrument for the assessment of depression with a self-report questionnaire. Participants will endorse the level of disturbance which best describe their mood over 21 items that are characteristic of depression.

Change in Anxiety

Beck Anxiety Inventory (BAI): The BAI is a self-report instrument for the assessment of anxiety. The BAI consists of 21 items, each describing a common symptom of anxiety on which the respondent rates how much they have been bothered by the symptoms over the last week.

Change in Frontal Systems Behavior Scale (FRSBE)

A validated self-report of three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction.

Change in Cognitive Self-Report Questionnaire (CSRQ)

A validated self-report questionnaire that assesses perceptions of cognition and mood related to everyday experiences for the past two weeks

Change in Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog)

Measures patient's perceived cognitive functioning as a result of their diagnosis and cancer therapy.

Change in Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-F)

A measure of one's perception of their level of Fatigue as a result to cancer therapy.

Secondary Outcome Measures

Full Information

NCT ID

NCT02515487

First Posted

July 28, 2015

Last Updated

February 2, 2018

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02515487

Brief Title

An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors

Official Title

An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

September 2013 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Post-chemotherapy, cognitive impairment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breast cancer patients receiving chemotherapy treatment

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Brain Fitness Program (BFP)

Intervention Description

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 Outcome Measure Information:

Title

Change in Wechsler Test of Adult Reading (WTAR)

Description

The WTAR is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.

Time Frame