Experience of Brain Tumor Caregivers

July 31, 2012 updated by: M.D. Anderson Cancer Center

The Experience of Informal Caregivers of Patients With Brain Tumors

The objective of this study is to explore the experience of informal caregivers of patients with a primary brain tumor, identifying elements and themes of the caregiving experience specific to this population of caregivers. The aim is to describe the experience of being an informal caregiver for a patient with a primary brain tumor.

Study Overview

Status

Completed

Conditions

Detailed Description

Caregiver Consent:

If you agree to take part in this study, you will be asked to have 1 interview. This will be a face-to-face interview that will take place at M. D. Anderson while you are there for the patient's physician appointment.

During this interview, you will be asked to describe what it has been like for you to help care for a person with a primary brain tumor in the past, what it is like to care for a person with a primary brain tumor now, and what you think it might be like in the future. You will be interviewed alone, and your interview will be tape recorded and then written on paper. The information that is gathered (the tape and the written information) will be kept strictly confidential. The tapes and any paperwork will be kept in a locked box during and after this study. The written information will be kept in password-protected computer files. The researcher is the only person who will have access to the tapes. You will also be asked to answer a questionnaire on paper. This questionnaire will ask specific personal information, such as your age, occupation, and relationship to the patient. This questionnaire will take about 5 minutes to complete. The entire interview will take about 30 minutes to complete.

Your participation in this study will be over after you complete the interview and the questionnaire.

This is an investigational study. Up to 20 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Patient Consent:

If you agree to take part in this study, you will be asked to choose a family member or a friend who is your main caregiver and who may be willing to take part in 1 interview for this study. Your consent in this study, will give researchers permission to contact your caregiver. If your caregiver chooses to participate, the interview will be face-to-face, and it will take place at M. D. Anderson while you are there for your physician appointment. During this interview, the caregiver will be asked to describe what it has been like for them to help care for you. The researcher will get informed consent from your caregiver and will go into further detail about this study.

He or she will be interviewed alone, and the information gathered during the interview will be kept strictly confidential. Your caregiver will be asked to complete a questionnaire for specific personal information, such as his or her age, occupation, and relationship to you. The entire interview will take about 30 minutes to complete.

You will be asked to allow your sociodemographic data (such as your gender, marital status, etc.) and medical data (such as your diagnosis, therapies received, etc.) to be collected from your medical record. This information will be used to help researchers learn about the unique backgrounds of the patients participating in this study. Your information that is gathered will be kept strictly confidential, and it will be kept in a locked box during and after this study.

Your participation in this study will be over after your sociodemographic and medical data have been collected from your medical record.

This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • U.T. M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary informal caregiver of individual with a primary brain glioma.

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. Ability to speak and read English
  3. Diagnosis of a primary brain glioma, World Health Organization Grade II-IV (PATIENT ONLY)
  4. At least 3 months since time of diagnosis (PATIENT ONLY)
  5. Identification as the primary informal caregiver by a patient with a primary brain glioma (CAREGIVER ONLY)
  6. Consent to participate

Exclusion Criteria:

  1. Inability to understand the intent of the study
  2. Medical condition that would preclude participation in an interview lasting 30 minutes (CAREGIVER ONLY)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interview + Questionnaire
Recorded face-to-face session.
Written survey lasting approximately 30 minutes.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Descriptive exploratory analysis to identify themes and describe experience of caring for a person with a primary brain tumor
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Loretta A. Williams, DSN, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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