or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain Tumor

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Mean Caregiver Ratings of Symptom Severity (using the mean of all the items from the MDASI-BT) in Patient-Caregiver Dyads

Outcome Time Frame:

Participant involvment is 10 minutes to complete MDASI-BT questionnaire

Safety Issue:

No

Principal Investigator

Mark R. Gilbert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0117

NCT ID:

NCT00748774

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Brain Tumor
  • Primary Brain Tumor
  • Caregivers
  • Symptom Severity
  • Questionnaire
  • M.D. Anderson Symptom Inventory-Brain Tumor
  • MDASI-BT
  • Brain Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030