Analysis of Neurocognitive Elements of Attention After Chemotherapy

Cancer Nos Clinical Trial

Official title:

Analysis of Neurocognitive Elements of Attention After Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052868
• Other study ID #: SCCC-08111
• Secondary ID: STU 032011-207
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: February 13, 2017
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2017
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Nos

Intervention

Other:
• Cognitive Assessment
Cognitive testing session

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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