Metastatic Malignant Neoplasm in the BrainPhase 2NCT05503251
Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases
A Phase 2 study testing Best Practice, Neuropsychological Assessment and Quality-of-Life Assessment in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the effect of neuropsychological evaluation and intervention in maintaining quality of life after radiation therapy in patients with cancer that has spread to the brain (metastases). Quality of life refers to the overall enjoyment of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Neuropsychological Assessment and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 30 Jun 2025
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage IV histologic diagnosis of solid tumor
- Patient will be treated with radiation therapy for brain metastases
- Primarily English-speaking patient
- Graded Prognostic Assessment (GPA) >= 2 (estimated survival > 6 months)
Who cannot join
- Patient received prior whole brain radiation therapy to the brain
- Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases - A Phase 2 Randomized Controlled Trial
This phase II trial studies the effect of neuropsychological evaluation and intervention in maintaining quality of life after radiation therapy in patients with cancer that has spread to the brain (metastases). Quality of life refers to the overall enjoyment of life. It holds varying meanings for different people and may evolve over time. For some individuals it implies autonomy, empowerment, capability, and choice; for others, security, social integration, or freedom from stress or illness. Neuropsychological evaluation is used to examine the cognitive (thinking) consequences of brain damage, brain disease, and severe mental illness. Deterioration of both quality of life and cognitive function is common when receiving radiation to the brain. Neuropsychological evaluation with a certified neuropsychologist may improve quality of life or cognitive function after radiation therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the efficacy of neuropsychological assessment and follow up on preventing decline of quality of life (QOL) as evaluated by the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) score (validated QOL tool for brain metastases).
SECONDARY OBJECTIVES:
- To evaluate the efficacy of early neuropsychological assessment and neurocognitive rehabilitation by a neuropsychologist on prevention of neurocognitive decline in patients treated with radiation to brain metastases as evaluated by the Hopkins Verbal Learning Test-Revised (HVLT-R) Delay Recall, Trail Making Test A/B (TMT A/B), and Controlled Oral Word Association Test (COWAT), and Patient Reported Outcomes Measurement Information System (PROMIS)-8 assessment.
II. To identify subsets of patients treated with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) who receive greater benefits of neuropsychologic evaluation through examining baseline Fact-Br, HVLT-R, TMT A/B, COWAT, and PROMIS-8 completed prior to radiation therapy delivery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
ARM II: Patients receive usual care.
After completion of standard of care radiation therapy, patients are followed up at 3, 6, and 12 months.
- Being tested
- Best Practice, Neuropsychological Assessment, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Neuropsychological AssessmentBehavioural
Also called Neuropsychological Examination
Undergo neuropsychological evaluation
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (neuropsychological evaluation) | Experimental | Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months. Receives: Behavioral: Neuropsychological Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients receive usual care. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QOL)
Will be measured by the Functional Assessment of Cancer Therapy Scale-Brain instrument. Linear models will be employed to measure QOL score (converted to a 0- to 100-point scale).
Measured: Up to 12 months after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start30 Aug 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the BrainStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Palmer, Ohio State University Comprehensive Cancer Center
- Investigators
- Joshua D Palmer, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503251
- Sponsor's protocol ID
- OSU-21074
- Other IDs
- NCI-2022-02216
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases - A Phase 2 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05503251
- Acronym / sponsor ID
- OSU-21074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Aug 2022 (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.
This phase II trial studies the effect of neuropsychological evaluation and intervention in maintaining quality of life after radiation therapy in patients with cancer that has spread to the brain (metastases). Quality of life refers to the overall enjoyment of life. It holds varying meanings for different people and may evolve over time. For some individuals it implies autonomy, empowerment, capability, and choice; for others, security, social integration, or freedom from stress or illness. Neuropsychological evaluation is used to examine the cognitive (thinking) consequences of brain damage, brain disease, and severe mental illness. Deterioration of both quality of life and cognitive function is common when receiving radiation to the brain. Neuropsychological evaluation with a certified neuropsychologist may improve quality of life or cognitive function after radiation therapy.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the efficacy of neuropsychological assessment and follow up on preventing decline of quality of life (QOL) as evaluated by the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) score (validated QOL tool for brain metastases).
SECONDARY OBJECTIVES:
- To evaluate the efficacy of early neuropsychological assessment and neurocognitive rehabilitation by a neuropsychologist on prevention of neurocognitive decline in patients treated with radiation to brain metastases as evaluated by the Hopkins Verbal Learning Test-Revised (HVLT-R) Delay Recall, Trail Making Test A/B (TMT A/B), and Controlled Oral Word Association Test (COWAT), and Patient Reported Outcomes Measurement Information System (PROMIS)-8 assessment.
II. To identify subsets of patients treated with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) who receive greater benefits of neuropsychologic evaluation through examining baseline Fact-Br, HVLT-R, TMT A/B, COWAT, and PROMIS-8 completed prior to radiation therapy delivery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
ARM II: Patients receive usual care.
After completion of standard of care radiation therapy, patients are followed up at 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (neuropsychological evaluation) | Experimental | Behavioral: Neuropsychological Assessment, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months. |
| Arm II (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IV histologic diagnosis of solid tumor
- Patient will be treated with radiation therapy for brain metastases
- Primarily English-speaking patient
- Graded Prognostic Assessment (GPA) >= 2 (estimated survival > 6 months)
Key exclusion criteria (2 listed)
- Patient received prior whole brain radiation therapy to the brain
- Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm II (usual care) |
| Neuropsychological AssessmentAlso: Neuropsychological ExaminationUndergo neuropsychological evaluation | Behavioural | Arm I (neuropsychological evaluation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (neuropsychological evaluation), Arm II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (neuropsychological evaluation), Arm II (usual care) |
Primary outcome
Quality of life (QOL)
Time frame: Up to 12 months after radiation therapy
Will be measured by the Functional Assessment of Cancer Therapy Scale-Brain instrument. Linear models will be employed to measure QOL score (converted to a 0- to 100-point scale).
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 21 Oct 2026.
- The JameslineLink provided by the sponsor.
- 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.
Joshua D Palmer, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Neuropsychological Assessment and Quality-of-Life Assessment in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 2 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 21 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of life (QOL) (time frame: Up to 12 months after radiation therapy). 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 21 Oct 2026.