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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090386
• Other study ID #: 16-005834
• Status: Completed
• Start date: February 25, 2017
• Est. completion date: November 15, 2020

Study information

• Verified date: November 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2018
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Communication Survey	Survey is completed at time of consent	1 day at time of consent
Secondary	Cognitive-linguistic Standardized Testing	Standardized testing will be completed	within 3 months of cognitive communication survey
Secondary	Follow-up Survey	Survey will be completed	within 6 months after completion of standardized testing

External Links

•   Mayo Clinic Clinical Trials