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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748774
• Other study ID #: 2008-0117
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: January 5, 2016
• Start date: May 2008
• Est. completion date: September 2014

Study information

• Verified date: January 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Behavioral:
• Questionnaire
Two questionnaires taking about 10 minutes to complete.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Caregiver Ratings of Symptom Severity (using the mean of all the items from the MDASI-BT) in Patient-Caregiver Dyads		Participant involvment is 10 minutes to complete MDASI-BT questionnaire	No

External Links

•   University of Texas MD Anderson Cancer Center Website