Malignant NeoplasmNCT01506440
Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
An observational study of Malignant Neoplasm and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Malignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- cognitive assessment and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated for the first time using standard chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- cognitive assessment, quality-of-life assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentProcedure or surgery
Given cognitive assessments
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: cognitive assessment; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 16 weeks after the start of chemotherapy
Secondary outcomes (2)
Changes in cognition over time
As measured by cognitive assessment instruments
Measured: Baseline to 16 weeks after the start of chemotherapy
Association of cognitive performance with performance status and adverse events (AE)
Measured: Baseline to 16 weeks after the start of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506440
- Sponsor's protocol ID
- IRB00018421
- Other IDs
- NCI-2011-03034, CCCWFU 99611
- Status last verified
- Jul 2018
- First submitted
- 21 Oct 2011
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
- ClinicalTrials.gov ID
- NCT01506440
- Acronym / sponsor ID
- IRB00018421
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.
SECONDARY OBJECTIVES:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (cognitive assessment) | – | Procedure: cognitive assessment, Procedure: quality-of-life assessmentPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated for the first time using standard chemotherapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive assessmentGiven cognitive assessments | Procedure or surgery | Supportive Care (cognitive assessment) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive Care (cognitive assessment) |
Primary outcome
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.
2 secondary outcomes
Changes in cognition over time
Time frame: Baseline to 16 weeks after the start of chemotherapy
Association of cognitive performance with performance status and adverse events (AE)
Time frame: Baseline to 16 weeks after the start of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Klepin, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.