Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 10:54 PM
Study NCT ID:
NCT01927393
Status:
WITHDRAWN
Last Update Posted:
2014-12-23
First Post:
2013-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2013-08-20', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)', 'timeFrame': 'Up to 6 months', 'description': 'The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design.'}, {'measure': 'Symptom burden using the FACT-Trial Outcome Index (TOI)', 'timeFrame': 'Up to 6 months', 'description': 'Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement.'}], 'secondaryOutcomes': [{'measure': 'Reduction in anxiety', 'timeFrame': 'Up to 6 months', 'description': 'Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic.'}, {'measure': 'Reduction in depression', 'timeFrame': 'Up to 6 months', 'description': 'Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic.'}, {'measure': 'Overall survival', 'timeFrame': 'At 6 months', 'description': 'Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables.'}, {'measure': 'Health care resource use including presence of advanced care planning, chemotherapy in the last 14 days of life, and length of time between hospice referral and death', 'timeFrame': 'Up to 6 months', 'description': 'Two way (2x2) ANOVAs will be conducted to test the differences between groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Recurrent Ovarian Epithelial Cancer', 'Recurrent Ovarian Germ Cell Tumor', 'Recurrent Pancreatic Cancer', 'Stage III Pancreatic Cancer', 'Stage IIIA Ovarian Epithelial Cancer', 'Stage IIIA Ovarian Germ Cell Tumor', 'Stage IIIB Ovarian Epithelial Cancer', 'Stage IIIB Ovarian Germ Cell Tumor', 'Stage IIIC Ovarian Epithelial Cancer', 'Stage IIIC Ovarian Germ Cell Tumor', 'Stage IV Ovarian Epithelial Cancer', 'Stage IV Ovarian Germ Cell Tumor', 'Stage IV Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.\n\nII. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.\n\nARM II: Patients receive standard care plus attention comprising two telephone contacts.\n\nAfter completion of study, patients are followed up at 1, 3, and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pancreatic or ovarian cancer\n* Confirmed stage III or IV disease\n* Patients who are within one year from initial diagnosis\n* Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations\n* Ability to read and/or understand the study protocol requirements, and provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01927393', 'briefTitle': 'Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers', 'orgStudyIdInfo': {'id': '13270'}, 'secondaryIdInfos': [{'id': 'NCI-2013-01629', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '13270', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (PCPI)', 'description': 'Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.', 'interventionNames': ['Other: palliative care', 'Behavioral: educational intervention', 'Procedure: quality-of-life assessment', 'Other: questionnaire administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (standard care plus attention control)', 'description': 'Patients receive standard care plus attention comprising two telephone contacts.', 'interventionNames': ['Procedure: quality-of-life assessment', 'Other: questionnaire administration', 'Behavioral: telephone-based intervention']}], 'interventions': [{'name': 'palliative care', 'type': 'OTHER', 'description': 'Receive PCPI', 'armGroupLabels': ['Arm I (PCPI)']}, {'name': 'educational intervention', 'type': 'BEHAVIORAL', 'otherNames': ['intervention, educational'], 'description': 'Receive education sessions', 'armGroupLabels': ['Arm I (PCPI)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (PCPI)', 'Arm II (standard care plus attention control)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (PCPI)', 'Arm II (standard care plus attention control)']}, {'name': 'telephone-based intervention', 'type': 'BEHAVIORAL', 'description': 'Receive telephone contacts', 'armGroupLabels': ['Arm II (standard care plus attention control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Virginia Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}