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Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506440
First Posted: January 10, 2012
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
October 21, 2011
January 10, 2012
May 30, 2017
October 2011
October 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01506440 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
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.

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients being treated for the first time using standard chemotherapy
  • Malignant Neoplasm
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Procedure: cognitive assessment
    Given cognitive assessments
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
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.
Interventions:
  • Procedure: cognitive assessment
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01506440
CCCWFU 99611
NCI-2011-03034 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Heidi Klepin, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
February 2017