Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

Study Visit: 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.


Criteria:

Inclusion Criteria: 1. Imaging consistent with a primary brain tumor or prior pathologic diagnosis of primary brain tumor 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: 1. Patients less than 18 years of age will be excluded from this study. 2. Patients will be excluded from the study if they are unable to complete the self-report questionnaire or participate in neurocognitive testing.


Study is Available At:


Original ID:

2008-0117


NCT ID:

NCT00748774


Secondary ID:


Study Acronym:


Brief Title:

Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)


Official Title:

Primary Brain Tumor Patient and Caregiver Congruence in Symptom Report Using the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

115


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mark R. Gilbert, MD
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:May 2008
Completion Date:September 2014
Completion Type:Actual
Primary Completion Date:September 2014
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 5, 2016
First Received Date:September 5, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mean Caregiver Ratings of Symptom Severity (using the mean of all the items from the MDASI-BT) in Patient-Caregiver Dyads
Time Frame:Participant involvment is 10 minutes to complete MDASI-BT questionnaire
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Questionnaire
Description:Two questionnaires taking about 10 minutes to complete.
Arm Name:MDASI-BT
Other Name:Survey

Study Arms

Study Arm Type:Other
Arm Name:MDASI-BT
Description:MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center

Samples and Retentions

Study Population: Individuals with a brain tumor who are going to have neurocognitive testing as part of routine care and their caregivers.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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