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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 30 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04075370
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Deborah Allen, PhD
Principal Investigator Affiliation Duke Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Brain Tumor, Brain Metastases, Adult
Additional Details

Cognitive impairments experienced by cancer survivors, from time of diagnosis through the health trajectory, are distressing, persistent, and negatively impact everyday function and quality of life. While reports of cancer- and treatment-related cognitive concerns vary substantially and may be underestimated in some diagnoses, the estimated incidence ranges from 30% in breast cancer up to 90% in brain cancers. Those with brain cancers, including both primary brain tumors and secondary brain metastases, often receive news of their diagnosis during prime productive years of their lives. Due to the cognitive effects from cancer or its treatment, most brain cancer survivors report difficulties returning to work or maintain family demands. Survivors often report co-occurring symptoms or a symptom cluster that include fatigue, sleep and mood disturbances, adding to multimorbidity conditions from the psychoneuroimmunologic effects of cancer. As medical advances have fostered significant gains in cancer survivorship and cancer is now recognized as a chronic illness, there is an urgency to address commonly faced symptoms and chronic conditions throughout the cancer trajectory beginning at time of diagnosis. Cancer treatment is designed to induce cell death but when treating brain cancers, treatment may negatively impact neurogenesis and neural repair. Previous study indicates that some survivors of brain tumors use behavioral compensation, the investigators aim to understand how neural compensation may be impacted. Cognitive functions associated with biomarkers (NComp) are brain-derived neurotrophic factor (BDNF), catechol-O-methyl transferase (COMT). As survival rises, the investigators need to identify factors that moderate cognitive function in order to develop interventions aimed at minimizing functional decline. This study is significant as it: 1) describes cognitive variability decline over time, and use of N/BComp; 2) uniquely explores cognition and N/BComp over time; 3) explores moderators of cognitive function across brain cancer survivors, 4) may lead to developing targeted cognitive interventions. Cognitive function impacts everyday functional abilities and quality of life, however, change in cognition can elude detection. Discrepancies observed between subjective and objective cognitive, co-occurring symptoms, and its relationship with cognitive reserve are new research areas of interest in oncology. Exploring neural or behavioral compensation within the context of cognitive reserve is novel. No known oncology studies have reported the relationship of neural and behavioral compensation with change in cognitive function over time. Examining the trajectory of these variables can aid in identifying potential cognitive interventions for targeted use to prevent decline or maintain function over time. This study is innovative because it is the first to explore the interface of neural/behavioral compensation and the cognitive trajectory, within a framework of cognitive reserve, in adults newly diagnosed with brain cancers.

Arms & Interventions

Arms

: 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).

Interventions

Other: - Neuropsychological Testing

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Deborah Allen, PhD RN

[email protected]

919-681-4719