Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT00352820
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2006-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Experience of Brain Tumor Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2006-07-13', 'studyFirstSubmitQcDate': '2006-07-13', 'lastUpdatePostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Descriptive exploratory analysis to identify themes and describe experience of caring for a person with a primary brain tumor', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Caregiver', 'Brain cancer', 'Glioma', 'Questionnaire', 'Survey', 'Interview'], 'conditions': ['Brain Cancer', 'Glioma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Caregiver Consent:\n\nIf 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.\n\nDuring 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.\n\nYour participation in this study will be over after you complete the interview and the questionnaire.\n\nThis is an investigational study. Up to 20 caregivers will take part in this study. All will be enrolled at M. D. Anderson.\n\nPatient Consent:\n\nIf 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.\n\nHe 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.\n\nYou 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.\n\nYour participation in this study will be over after your sociodemographic and medical data have been collected from your medical record.\n\nThis is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary informal caregiver of individual with a primary brain glioma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older\n2. Ability to speak and read English\n3. Diagnosis of a primary brain glioma, World Health Organization Grade II-IV (PATIENT ONLY)\n4. At least 3 months since time of diagnosis (PATIENT ONLY)\n5. Identification as the primary informal caregiver by a patient with a primary brain glioma (CAREGIVER ONLY)\n6. Consent to participate\n\nExclusion Criteria:\n\n1. Inability to understand the intent of the study\n2. Medical condition that would preclude participation in an interview lasting 30 minutes (CAREGIVER ONLY)'}, 'identificationModule': {'nctId': 'NCT00352820', 'briefTitle': 'Experience of Brain Tumor Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'The Experience of Informal Caregivers of Patients With Brain Tumors', 'orgStudyIdInfo': {'id': '2006-0019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interview + Questionnaire', 'interventionNames': ['Behavioral: Interview', 'Behavioral: Questionnaire']}], 'interventions': [{'name': 'Interview', 'type': 'BEHAVIORAL', 'description': 'Recorded face-to-face session.', 'armGroupLabels': ['Interview + Questionnaire']}, {'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Written survey lasting approximately 30 minutes.', 'armGroupLabels': ['Interview + Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'U.T. M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Loretta A. Williams, DSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}