Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-10 @ 5:12 PM
Study NCT ID:
NCT00634257
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2008-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spirituality/Religiosity in Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2008-02-25', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between self-rated spirituality/religiosity and coping strategies', 'timeFrame': 'Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancer', 'Solid Tumors', 'Spirituality', 'Religiosity', 'Symptom Distress', 'Quality of Life', 'Caregivers', 'Questionnaire', 'Survey'], 'conditions': ['Advanced Cancer', 'Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\n-To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.\n\nSecondary Objectives:\n\n* To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.\n* To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).\n* To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).\n* To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question).", 'detailedDescription': 'Questionnaires:\n\nIf you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.\n\nThe first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.\n\nThe 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)\n\nThe last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.\n\nLength of Study Participation:\n\nAfter completing the questionnaires, your participation in this study will be over.\n\nThis is an investigational study. Up to 100 patients and 100 caregivers 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': 'Patients with advanced cancer receiving palliative care and their primary caregivers.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. (Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center\n2. (Patients) Patients aged 18 years or over\n3. (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures).\n4. (Patients) Able to provide informed consent and comply with study procedures\n5. (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living\n6. (Caregivers) Having the patient's consent to be contacted.\n7. (Caregivers) Caregiver is 18 years or over\n8. (Caregivers) Able to provide informed consent and comply with study procedures\n9. (Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.\n10. (Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.\n11. (Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.\n\nExclusion Criteria:\n\nN/A"}, 'identificationModule': {'nctId': 'NCT00634257', 'briefTitle': 'Spirituality/Religiosity in Patients and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers', 'orgStudyIdInfo': {'id': '2007-0678'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02785', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with advanced cancer receiving palliative care.', 'interventionNames': ['Behavioral: Questionnaires']}, {'label': 'Caregivers', 'description': 'Primary caregivers of Patients with advanced cancer receiving palliative care.', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Nine questionnaires taking about 40 minutes to complete.', 'armGroupLabels': ['Caregivers', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Eduardo Bruera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}