Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cognitive Changes in Adult Cancer Survivors

NCT01569932

Effects of Chemotherapy Cognitive Impairment

COMPLETED

Communication Effectiveness in Cancer Treatment

NCT02197091

Malignant Neoplasm

COMPLETED

Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer

NCT00410618

Cognitive/Functional Effects Colorectal Cancer Long-term Effects Secondary to Cancer Therapy in Adults

COMPLETED

Chemotherapy Induced Cognitive Impairment

NCT05740787

Breast Cancer

RECRUITING

Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI

NCT03137095

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm Unspecified Adult Solid Tumor, Protocol Specific

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

cognitive assessment

Intervention Type PROCEDURE

Given cognitive assessments

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive assessment

Given cognitive assessments

Intervention Type PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

quality of life assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No