Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients

November 30, 2020 updated by: Nadia N. Laack, M.D., Mayo Clinic
This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adults diagnosed with a malignant brain tumor either as a primary diagnosis or recurrent

Description

Inclusion Criteria:

  • be between18 to 89 years old;
  • have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery)
  • have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study;
  • be native speakers of American English;
  • have obtained a minimum of a high school education;
  • self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; and
  • must demonstrate capacity to sign informed consent based on Informed Consent for Research: A Guide to Assessing a Participant's Understanding tool.

Exclusion Criteria:

  • are younger than 18 years old or older than 89 years old;
  • have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery)
  • have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment;
  • are not native speakers of American English;
  • have not obtained a minimum of a high school education;
  • do not self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; or
  • do not demonstrate the capacity to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Communication Survey
Time Frame: 1 day at time of consent
Survey is completed at time of consent
1 day at time of consent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive-linguistic Standardized Testing
Time Frame: within 3 months of cognitive communication survey
Standardized testing will be completed
within 3 months of cognitive communication survey
Follow-up Survey
Time Frame: within 6 months after completion of standardized testing
Survey will be completed
within 6 months after completion of standardized testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2017

Primary Completion (Actual)

November 15, 2018

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-005834

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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