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

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.
 
ClinicalTrials.gov Identifier: NCT03090386
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Nadia N. Laack, M.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Tumor Other: Cognitive Surveys

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients
Actual Study Start Date : February 25, 2017
Actual Primary Completion Date : November 15, 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors


Intervention Details:
  • Other: Cognitive Surveys
    Complete the Cognitive Communication Survey, standardized cognitive and language assessments, and the Follow-up Cognitive Communication Survey after treatment


Primary Outcome Measures :
  1. Cognitive Communication Survey [ Time Frame: 1 day at time of consent ]
    Survey is completed at time of consent


Secondary Outcome Measures :
  1. Cognitive-linguistic Standardized Testing [ Time Frame: within 3 months of cognitive communication survey ]
    Standardized testing will be completed

  2. Follow-up Survey [ Time Frame: within 6 months after completion of standardized testing ]
    Survey will be completed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090386


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

Additional Information:
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Responsible Party: Nadia N. Laack, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03090386     History of Changes
Other Study ID Numbers: 16-005834
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases