Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)
Primary Brain Tumor Patient and Caregiver Congruence in Symptom Report Using the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)
1 other identifier
observational
115
1 country
1
Brief Summary
The goal of this study is to compare patient ratings of how severe their own symptoms may be, with their caregivers' ratings of how severe they think the patients' symptoms may be. This will be compared using a questionnaire that is given to patients with brain tumors and their caregivers. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJanuary 7, 2016
January 1, 2016
6.3 years
September 5, 2008
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Caregiver Ratings of Symptom Severity (using the mean of all the items from the MDASI-BT) in Patient-Caregiver Dyads
Participant involvment is 10 minutes to complete MDASI-BT questionnaire
Study Arms (1)
MDASI-BT
MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.
Interventions
Two questionnaires taking about 10 minutes to complete.
Eligibility Criteria
Individuals with a brain tumor who are going to have neurocognitive testing as part of routine care and their caregivers.
You may qualify if:
- Imaging consistent with a primary brain tumor or prior pathologic diagnosis of primary brain tumor
- Referred for neurocognitive function testing as part of the plan of care
- Age \> or = 18 years of age
- Ability to speak, read, and write the English language
- Caregiver Attribute: Identified by the patient as being primarily involved in the patients' care in the home setting (biologic, legal, or functional relationship)
- Caregiver Attribute: Able to speak, read, and write the English language
- Both patient and caregiver have to agree to participate
- The caregiver needs to be present at the time the patient is recruited
You may not qualify if:
- Patients less than 18 years of age will be excluded from this study.
- Patients will be excluded from the study if they are unable to complete the self-report questionnaire or participate in neurocognitive testing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark R. Gilbert, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 9, 2008
Study Start
May 1, 2008
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
January 7, 2016
Record last verified: 2016-01