Analysis of Neurocognitive Elements of Attention After Chemotherapy

NCT ID: NCT03052868

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-05-31

Brief Summary

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.

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.

Conditions

Cancer Nos

Study Design

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

Study Groups

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.

Group Type: OTHER

Cognitive Assessment

Intervention Type: OTHER

Cognitive testing session

Interventions

Cognitive Assessment

Cognitive testing session

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C. Munro Cullum, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Other Identifiers

STU 032011-207

Identifier Type: OTHER

Identifier Source: secondary_id

SCCC-08111

Identifier Type: -

Identifier Source: org_study_id