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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00748774
First received: September 5, 2008
Last updated: May 6, 2013
Last verified: May 2013

September 5, 2008
May 6, 2013
May 2008
May 2015   (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
Not Provided
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 ]
Not Provided
Not Provided
 
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Individuals with a brain tumor who are going to have neurocognitive testing as part of routine care and their caregivers.

Brain Tumor
Behavioral: Questionnaire
Two questionnaires taking about 10 minutes to complete.
Other Name: Survey
MDASI-BT
MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
May 2015   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00748774
2008-0117
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Mark R. Gilbert, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2013

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