Primary Brain TumorNCT04075370
Exploring Compensation to Maintain Cognitive Function in Adults Newly Diagnosed With Brain Cancer
An observational study of Primary Brain Tumor and Brain Metastases, Adult, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Primary Brain Tumor, Brain Metastases, Adult
- What is being tested?
- Neuropsychological Testing
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from the appropriate clinics within a large academic health care setting.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Primary Brain Tumor, Brain Metastases, Adult
- Being tested
- Neuropsychological Testing
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological TestingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Neuropsychological Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
Serial neurocognitive testing using composite scores from the Trail Making A and B test
Measured: 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
Measured: 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
Measured: Baseline, 2 weeks and 3 months post radiation therapy
Secondary outcomes (4)
Change in cognitive function
Composite scores will be computed using the Functional Assessment of Cancer Cognition Scale
Measured: Baseline and up to 3 months post XRT
Change in cognitive function
Composite scores will be computed using the Functional Assessment of Cancer-Treatment Cognition Scale
Measured: Baseline and up to 3 months post XRT
Change in cognition reserve
Composite scores will be computed using the Hollingshead Index
Measured: Baseline and up to 3 months post XRT
Change in cognition reserve
Composite scores will be computed using the North American Adult Reading Test
Measured: Baseline and up to 3 months post XRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start22 Jul 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Allen, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075370
- Sponsor's protocol ID
- Pro00092580
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2019
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Compensation to Maintain Cognitive Function in Adults Newly Diagnosed With Brain Cancer
- ClinicalTrials.gov ID
- NCT04075370
- Acronym / sponsor ID
- Pro00092580
- Conditions
- Primary Brain Tumor, Brain Metastases, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | – | Other: Neuropsychological TestingIn 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). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the appropriate clinics within a large academic health care setting.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological TestingMeasure 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. | Other | Single arm study |
Primary outcome
Change in cognitive function
Time frame: Baseline, 2 weeks and 3 months post radiation therapy
Serial neurocognitive testing using composite scores from the Trail Making A and B test
Change in cognitive function
Time frame: Baseline, 2 weeks and 3 months post radiation therapy
Serial neurocognitive testing using composite scores from the Controlled Oral Word Association (COWA) test
Change in cognitive function
Time frame: Baseline, 2 weeks and 3 months post radiation therapy
Serial neurocognitive testing using the composite scores from the Hopkins Verbal Learning Test
4 secondary outcomes
Change in cognitive function
Time frame: Baseline and up to 3 months post XRT
Change in cognitive function
Time frame: Baseline and up to 3 months post XRT
Change in cognition reserve
Time frame: Baseline and up to 3 months post XRT
Change in cognition reserve
Time frame: Baseline and up to 3 months post XRT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Allen, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brain Tumor and Brain Metastases, Adult, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: Baseline, 2 weeks and 3 months post radiation therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.