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

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

Purpose

Primary Objective:

1. To estimate the mean caregiver ratings of symptom severity (using the mean of all the items from the MDASI-BT) in patient-caregiver dyads.

Secondary Objective:

To evaluate the feasibility of use of the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) by caregiver proxy rating of symptoms in patients with primary brain tumors.
To evaluate the reliability and known groups validity of caregiver proxy ratings.
To describe differences in the mean symptom severity and symptom interference among patients referred for presurgery assessment of neurocognitive function (NCF) testing and those referred for evaluation of possible NCF deficits across the disease trajectory.
To describe differences in patient/caregiver congruence for those patients determined to have cognitive impairment versus those with no impairment by NCF testing.
To evaluate correlations among patient self-report and caregiver report of the patient's problems with memory and concentration with evaluation by neurocognitive testing.

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:

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: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with a primary brain tumor and their caregivers.	Behavioral: Questionnaire Two questionnaires taking about 10 minutes to complete.

Show Detailed Description

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:	March 20, 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

Study placed in the following topic categories:

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

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 July 06, 2009