Analysis of Neurocognitive Elements of Attention After Chemotherapy

Data for this study will be obtained from the University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center. Participants will be recruited through Simmons Cancer Center. One hundred female breast cancer patients who have completed adjuvant chemotherapy will be enrolled. In order to reach this number, it is estimated that up to 125 eligible participants will need to be recruited. The study will last approximately two years. Participants will undergo one cognitive testing session, and each subject's total participation time will last no more than two hours.

Study Overview

• Status: Completed
• Conditions: Cancer Nos
• Intervention / Treatment: Other: Cognitive Assessment

Detailed Description

The study visit will be scheduled for three to six months after completing adjuvant chemotherapy treatment. At the study visit, informed consent will be obtained and neurocognitive attention testing will be performed. The assessments chosen were carefully selected based on breadth, psychometric properties, standardized broad clinical use, good external validity and time efficiency. The testing time for the battery of neuropsychological tests is approximately 45-60 minutes. Participants will also be asked to complete a packet of several questionnaires including several self-rated measures of mood and quality of life, in addition to a brief questionnaire to obtain information about exercise, sleep, and education and employment backgrounds. It is estimated that questionnaire completion will require no more than 30 minutes. Participants will be seen on only one occasion, and may receive, upon request, written feedback about the results of the evaluation.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women;
• diagnosed with breast cancer Stages I-IV; and
• completed a treatment regimen of adjuvant chemotherapy three to six months prior to evaluation.

Patients may be receiving anti-hormonal treatment. All subjects will be native speakers of English who have a minimum of a high school education (or GED equivalent) in order to ensure the validity of the neuropsychological tests that will be administered. In order to limit age effects, participants will be between the ages of 40 and 70 years.

Exclusion Criteria:

• Subjects with a previous history of stroke, head injury with loss of consciousness greater than 30 minutes, major surgeries within the past 6 months unrelated to their breast cancer treatment, pre-cancer major Axis I psychiatric disorder, diagnosis of adult Attention Deficit Disorder, or other pre-existing disorder with known cognitive impairments (e.g. dementia, intellectual disability) will be excluded.
• Non- English speakers and subjects under the age of 40 or over the age of 70 will not be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Data Collection; The study visit will be scheduled for three to six months after completing adjuvant chemotherapy treatment. At the study visit, informed consent will be obtained and neurocognitive attention testing will be performed. The assessments chosen were carefully selected based on breadth, psychometric properties, standardized broad clinical use, good external validity and time efficiency. The testing time for the battery of neuropsychological tests is approximately 45-60 minutes. Participants will also be asked to complete a packet of several questionnaires including several self-rated measures of mood and quality of life, in addition to a brief questionnaire to obtain information about exercise, sleep, and education and employment backgrounds. It is estimated that questionnaire completion will require no more than 30 minutes. Participants will be seen on only one occasion, and may receive, upon request, written feedback about the results of the evaluation.

Other: Cognitive Assessment; Cognitive testing session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of cognitive outcomes of cancer treatment in breast cancer	battery of neuropsychological tests is approximately 45-60 minutes. Participants will also be asked to complete a packet of several questionnaires including several self-rated measures of mood and quality of life, in addition to a brief questionnaire to obtain information about exercise, sleep, and education and employment backgrounds	1 day

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: C. Munro Cullum, PhD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SCCC-08111; STU 032011-207 (OTHER: UT Southwestern Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO