Brain CancerNCT00352820
Experience of Brain Tumor Caregivers
An observational study of Brain Cancer and Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Cancer, Glioma
- What is being tested?
- Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary informal caregiver of individual with a primary brain glioma.
Who may be able to join
- 18 years of age or older
- Ability to speak and read English
- Diagnosis of a primary brain glioma, World Health Organization Grade II-IV (PATIENT ONLY)
- At least 3 months since time of diagnosis (PATIENT ONLY)
- Identification as the primary informal caregiver by a patient with a primary brain glioma (CAREGIVER ONLY)
- Consent to participate
Who cannot join
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview lasting 30 minutes (CAREGIVER ONLY)
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Cancer, Glioma
- Being tested
- Interview, Questionnaire
- Keywords
- Caregiver, Brain cancer, Glioma, Questionnaire, Survey, Interview
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Recorded face-to-face session.
QuestionnaireBehavioural
Also called Survey
Written survey lasting approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Interview + Questionnaire | Not described Receives: Behavioral: Interview; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive exploratory analysis to identify themes and describe experience of caring for a person with a primary brain tumor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loretta A. Williams, DSN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352820
- Sponsor's protocol ID
- 2006-0019
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2006
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Informal Caregivers of Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00352820
- Acronym / sponsor ID
- 2006-0019
- Conditions
- Brain Cancer, Glioma
- Keywords
- Caregiver, Brain cancer, Glioma, Questionnaire, Survey, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 17 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview + Questionnaire | – | Behavioral: Interview, Behavioral: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary informal caregiver of individual with a primary brain glioma.
Key inclusion criteria (6 listed)
- 18 years of age or older
- Ability to speak and read English
- Diagnosis of a primary brain glioma, World Health Organization Grade II-IV (PATIENT ONLY)
- At least 3 months since time of diagnosis (PATIENT ONLY)
- Identification as the primary informal caregiver by a patient with a primary brain glioma (CAREGIVER ONLY)
Key exclusion criteria (2 listed)
- Inability to understand the intent of the study
- Medical condition that would preclude participation in an interview lasting 30 minutes (CAREGIVER ONLY)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewRecorded face-to-face session. | Behavioural | Interview + Questionnaire |
| QuestionnaireAlso: SurveyWritten survey lasting approximately 30 minutes. | Behavioural | Interview + Questionnaire |
Primary outcome
Descriptive exploratory analysis to identify themes and describe experience of caring for a person with a primary brain tumor
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Brain Cancer
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta A. Williams, DSN principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive exploratory analysis to identify themes and describe experience of caring for a person with a primary brain tumor (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.