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Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences Identifier:
First received: October 21, 2011
Last updated: February 20, 2017
Last verified: February 2017
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.

Condition Intervention
Malignant Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: cognitive assessment
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy. [ Time Frame: Baseline to 16 weeks after the start of chemotherapy ]
    To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.

Secondary Outcome Measures:
  • Changes in cognition over time [ Time Frame: Baseline to 16 weeks after the start of chemotherapy ]
    As measured by cognitive assessment instruments

  • Association of cognitive performance with performance status and adverse events (AE) [ Time Frame: Baseline to 16 weeks after the start of chemotherapy ]

Enrollment: 29
Actual Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Given cognitive assessments
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:


I. To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.


I. To estimate the variability of the various cognitive tests and to assess changes in cognitive performance based on the results of cognitive assessments obtained prior to chemotherapy and at 6 to 8 weeks and 12 to 16 weeks after the initiation of chemotherapy.

II. To explore the association of cognitive performance with the Eastern Cooperative Oncology Group (ECOG) performance status as evaluated by the patient's oncology team.

III. To assess the association between cognitive performance and the occurrence of a serious adverse event during chemotherapy.


Patients complete cognitive assessments, comprising Hopkins Verbal Learning Test-Revised (HVLT-R), Trail Making Test Parts A & B (TMT-A, TMT-B), Digit Symbol Coding Test (DSC), Category Fluency Test (Animals), Montreal Cognitive Assessment (MoCA), and Digit Span Test (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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients being treated for the first time using standard chemotherapy

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01506440

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Heidi Klepin, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences Identifier: NCT01506440     History of Changes
Other Study ID Numbers: CCCWFU 99611
NCI-2011-03034 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: October 21, 2011
Last Updated: February 20, 2017

Additional relevant MeSH terms:
Neoplasms processed this record on April 28, 2017