Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases
Primary Purpose
Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Neuropsychological Assessment
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Malignant Neoplasm in the Brain
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patient received prior whole brain radiation therapy to the brain
- Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
Sites / Locations
- Ohio State University Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (neuropsychological evaluation)
Arm II (usual care)
Arm Description
Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
Patients receive usual care.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05503251
First Posted
August 9, 2022
Last Updated
November 18, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05503251
Brief Title
Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases
Official Title
Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases - A Phase 2 Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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:
I. 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:
I. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (neuropsychological evaluation)
Arm Type
Experimental
Arm Description
Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
Arm Title
Arm II (usual care)
Arm Type
Active Comparator
Arm Description
Patients receive usual care.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological Assessment
Other Intervention Name(s)
Neuropsychological Examination
Intervention Description
Undergo neuropsychological evaluation
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Quality of life (QOL)
Description
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).
Time Frame
Up to 12 months after radiation therapy
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Patient received prior whole brain radiation therapy to the brain
Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua D Palmer, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua D. Palmer, MD
Email
joshua.palmer@osumc.edu
First Name & Middle Initial & Last Name & Degree
Joshua D. Palmer, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases
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