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

NCT03090386 | Completed

• 1 other identifier: 16-005834
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Cognitive Communication Survey

  Survey is completed at time of consent

  1 day at time of consent

Secondary Outcomes (2)

• Cognitive-linguistic Standardized Testing

  within 3 months of cognitive communication survey

• Follow-up Survey

  within 6 months after completion of standardized testing

Interventions

Cognitive Surveys OTHER

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 24, 2017
• Study Start: February 25, 2017
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

US (1)