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Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)
This study is currently recruiting participants.
Study NCT00748774   Information provided by M.D. Anderson Cancer Center
First Received: September 5, 2008   Last Updated: September 4, 2009   History of Changes

September 5, 2008
September 4, 2009
May 2008
May 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00748774 on ClinicalTrials.gov Archive Site
 
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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
 
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)

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 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.

 
Observational
Case Control, Prospective
Brain Tumor
Behavioral: Questionnaire
MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
240
 
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Mark R. Gilbert, MD 713-745-4621
United States
 
NCT00748774
Mark R. Gilbert, MD/Professor, U.T.M.D. Anderson Cancer Center
2008-0117
M.D. Anderson Cancer Center
 
Principal Investigator: Mark R. Gilbert, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP