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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748774
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : January 7, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Brain Tumor Behavioral: Questionnaire

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Primary Brain Tumor Patient and Caregiver Congruence in Symptom Report Using the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)
Study Start Date : May 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.
Behavioral: Questionnaire
Two questionnaires taking about 10 minutes to complete.
Other Name: Survey

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a brain tumor who are going to have neurocognitive testing as part of routine care and their caregivers.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748774

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Mark R. Gilbert, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00748774     History of Changes
Other Study ID Numbers: 2008-0117
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by M.D. Anderson Cancer Center:
Primary Brain Tumor
Symptom Severity
M.D. Anderson Symptom Inventory-Brain Tumor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases