Exploring Compensation to Maintain Cognitive Function in Adults Newly Diagnosed With Brain Cancer

NCT04075370 | Completed

• 1 other identifier: Pro00092580
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Recent research indicates that variability in cognitive function for brain tumor survivors may be explained by differences in cognitive reserve (CR) and use of compensatory strategies.However, it is unknown when cognitive function declines or survivors tap into compensation. This longitudinal mixed methods study proposes to explore differences in cognitive function and change over time in newly diagnosed adults with brain cancer prior to, immediately after (within 2 weeks), and 2-3 months after radiation therapy treatment has been completed. Specific aims are to: Aim1: Examine the relationship between objective and subjective cognitive function in subjects newly diagnosed with brain cancer prior to and after XRT. Aim 2: Explore the interrelationship between cognitive function and compensation (neural and behavioral) by high/low CR prior to and after XRT. Aim 3: Describe the trajectory of objective and subjective cognitive function over time by CR, cancer type, and associated treatment-related factors.

Conditions

Primary Brain Tumor; Brain Metastases, Adult

Outcome Measures

Primary Outcomes (3)

• Change in cognitive function

  Serial neurocognitive testing using composite scores from the Trail Making A and B test

  Baseline, 2 weeks and 3 months post radiation therapy

• Change in cognitive function

  Serial neurocognitive testing using composite scores from the Controlled Oral Word Association (COWA) test

  Baseline, 2 weeks and 3 months post radiation therapy

• Change in cognitive function

  Serial neurocognitive testing using the composite scores from the Hopkins Verbal Learning Test

  Baseline, 2 weeks and 3 months post radiation therapy

Secondary Outcomes (4)

• Change in cognitive function

  Baseline and up to 3 months post XRT

• Change in cognitive function

  Baseline and up to 3 months post XRT

• Change in cognition reserve

  Baseline and up to 3 months post XRT

• Change in cognition reserve

  Baseline and up to 3 months post XRT

Study Arms (1)

Single arm study

In this feasibility study, longitudinal mixed methods will be used to measure cognitive function and symptoms by objective tests, interviews, and biomarker assay in adults with brain cancer over time: prior to radiation (XRT; T1), 2-weeks post-XRT (T2), 2-3 months post-XRT (T3).

Other: Neuropsychological Testing

Interventions

Neuropsychological Testing OTHER

Measure cognition function and cognitive reserve in patients before, during and after radiation therapy using cumulative scores of Hollingshead Index, North American Adult Reading Test, HVLT-R, TMT A\&B and COWA over time.

Single arm study

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from the appropriate clinics within a large academic health care setting.

You may qualify if:

• Aged 30-65 years,
• Newly diagnosed with primary brain tumor or secondary brain metastases
• Able to read and write English as the neurocognitive testing will be administered using English language forms

You may not qualify if:

• Those with \>moderate cognitive impairment (Mini-Mental Status Examination \[MMSE\] score\<24) at baseline
• Aphasia
• Other neurodegenerative disorders Drink 3 or more alcoholic beverages per day (per Centers for Disease Control definition), report current use of illicit drugs/misuse of prescription medication, or currently undergoing treatment or had previous treatment for substance abuse at any time period (alcoholism or drug abuse).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for biomarker testing: ELISA ( optional gentyping), BDNF and COMT

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Deborah Allen, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 30, 2019
• Study Start: July 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)