Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)
NCT ID: NCT00748774
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
115 participants
OBSERVATIONAL
2008-05-31
2014-09-30
Brief Summary
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Researchers will also study any effects that these patients' neurocognitive function may have on these patients' and their caregivers' ratings of how severe the brain cancer symptoms may be.
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Detailed Description
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If you and your caregiver agree to take part in this study, you will both complete 2 questionnaires. You will be in separate rooms when you complete the questionnaires.
The first questionnaire is a demographic questionnaire that asks basic questions such as your age and employment status.
Your second questionnaire asks about any brain cancer symptoms that you may be experiencing, and asks you to rate how severe they may be.
Your caregiver's second questionnaire asks the same questions as yours. It asks the caregiver to rate how severe he or she believes your symptoms may be.
In total, the questionnaires should take about 10 minutes to complete.
Symptom Review:
The study staff will review the questionnaire responses right away. If you rate any symptom as severe as 7 or higher, the study staff will tell you to contact your doctor who is treating the cancer. The study staff will also contact your doctor who is treating the cancer. Otherwise, your questionnaire responses will only be used for research and there are no plans to contact your doctor.
Length of Study Participation:
After you and your caregiver complete the questionnaires this one time, your and your caregivers' active participation in this study will be over.
The study chair will also collect information from your medical record. This information will include your medical history and the results of the neurocognitive testing (routine tests of "thinking" skills such as your memory and concentration).
This is an investigational study. Up to 120 patients and 120 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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MDASI-BT
MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.
Questionnaire
Two questionnaires taking about 10 minutes to complete.
Interventions
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Questionnaire
Two questionnaires taking about 10 minutes to complete.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Referred for neurocognitive function testing as part of the plan of care
3. Age \> or = 18 years of age
4. Ability to speak, read, and write the English language
5. Caregiver Attribute: Identified by the patient as being primarily involved in the patients' care in the home setting (biologic, legal, or functional relationship)
6. Caregiver Attribute: Able to speak, read, and write the English language
7. Both patient and caregiver have to agree to participate
8. The caregiver needs to be present at the time the patient is recruited
Exclusion Criteria
2. Patients will be excluded from the study if they are unable to complete the self-report questionnaire or participate in neurocognitive testing.
18 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mark R. Gilbert, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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2008-0117
Identifier Type: -
Identifier Source: org_study_id
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