Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

NCT01506440 | Completed

• 3 other identifiers: IRB00018421NCI-2011-03034CCCWFU 99611
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies cognitive assessments in patients with cancer undergoing chemotherapy. Questionnaires that measure cognitive changes during chemotherapy may help identify the side effects of chemotherapy.

Conditions

Malignant Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.

  To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.

  Baseline to 16 weeks after the start of chemotherapy

Secondary Outcomes (2)

• Changes in cognition over time

  Baseline to 16 weeks after the start of chemotherapy

• Association of cognitive performance with performance status and adverse events (AE)

  Baseline to 16 weeks after the start of chemotherapy

Study Arms (1)

Supportive Care (cognitive assessment)

Patients complete cognitive assessments, comprising HVLT-R, TMT-A, TMT-B, DSC, Animals, MoCA, and DST. Patients also complete the Beck Depression Inventory. Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.

Procedure: cognitive assessment; Procedure: quality-of-life assessment

Interventions

cognitive assessment PROCEDURE

Given cognitive assessments

Supportive Care (cognitive assessment)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Supportive Care (cognitive assessment)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being treated for the first time using standard chemotherapy

You may qualify if:

• Patients must have histologically or cytologically confirmed cancer
• Patients are candidates for systemic chemotherapy for their cancer diagnosis
• Life expectancy must be greater than 6 months
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Patients who have had prior systemic chemotherapy in their lifetime
• Patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• Patients may not be participating on any other study investigating cognitive function
• Patients who are non-English speaking are ineligible
• Patients with hematologic malignancies are ineligible
• Patients with primary central nervous system malignancies are ineligible

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Heidi Klepin, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: January 10, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)