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Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01506440
First received: October 21, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2011
Primary Completion Date: July 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:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients being treated for the first time using standard chemotherapy

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506440

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Julia Lawrence Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01506440     History of Changes
Other Study ID Numbers: CCCWFU 99611, NCI-2011-03034
Study First Received: October 21, 2011
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013