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

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00748774

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.

Condition	Intervention
Brain Tumor	Behavioral: Questionnaire

Study Type:	Observational
Study Design:	Case Control, 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)

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Caregivers

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	240
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
MDASI-BT 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

Inclusion Criteria:

Imaging consistent with a primary brain tumor or prior pathologic diagnosis of primary brain tumor
Referred for neurocognitive function testing as part of the plan of care
Age > or = 18 years of age
Ability to speak, read, and write the English language
Caregiver Attribute: Identified by the patient as being primarily involved in the patients' care in the home setting (biologic, legal, or functional relationship)
Caregiver Attribute: Able to speak, read, and write the English language
Both patient and caregiver have to agree to participate
The caregiver needs to be present at the time the patient is recruited

Exclusion Criteria:

Patients less than 18 years of age will be excluded from this study.
Patients will be excluded from the study if they are unable to complete the self-report questionnaire or participate in neurocognitive testing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748774

Contacts

Contact: Mark R. Gilbert, MD

713-745-4621

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Mark R. Gilbert, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Mark R. Gilbert, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Mark R. Gilbert, MD/Professor )
Study ID Numbers:	2008-0117
Study First Received:	September 5, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00748774 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Primary Brain Tumor
Caregivers
Symptom Severity

Questionnaire
M.D. Anderson Symptom Inventory-Brain Tumor
MDASI-BT

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009