NCT00748774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

6.3 years

First QC Date

September 5, 2008

Last Update Submit

January 5, 2016

Conditions

Keywords

Primary Brain TumorCaregiversSymptom SeverityQuestionnaireM.D. Anderson Symptom Inventory-Brain TumorMDASI-BT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MDASI-BT

MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) questionnaire given to patients with a primary brain tumor and their caregivers.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Two questionnaires taking about 10 minutes to complete.

Also known as: Survey
MDASI-BT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mark R. Gilbert, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations