Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-03-05 @ 11:30 PM
Study NCT ID:
NCT03222258
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2017-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2017-07-16', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Overall QOL of EORTC QLQ - Core 15 at 6 months items', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care'}], 'secondaryOutcomes': [{'measure': 'Patients survival and Physicians Orders for Life Sustaining Treatment (POLST) documentation', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Patients survival and POLST(Physician Order for Life-Sustaining Treatment) documentation whether patients survive during the study period and write POLST documentation (Since POLST has no legal form in Korea, it is based on the format of each institution.)'}, {'measure': 'Patient Health Questionnaire-9', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '"Patient Health Questionnaire-9 items" is used as assessment tool to measure depression of both patients and their caregivers by completing the questionnaire.'}, {'measure': 'Decision Conflict Scale', 'timeFrame': 'Baseline, 6 months', 'description': '"Decision Conflict Scale" is used as assessment tool to measure a level of decision conflict in treatment of both patients and their caregivers by completing the questionnaire.'}, {'measure': 'Understanding the illness', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': "to measure the awareness of patients' status of prognosis in both patients and caregivers through two questions in the questionnaire. The first question is about the idea of the possibility of curing the patient's disease and asks patients thought about whether treatment is available for cure and prolong survival. The second question concerns the life expectancy of the patient."}, {'measure': 'Self-reported Health Status', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'to measure the perceived holistic health status(physical, mental, social, spiritual and general) in both patients and caregivers. caregivers (The patient is asked to answer the perceived health status into five stages.)'}, {'measure': 'KG-7(The Korean Cancer Study Group Geriatric Score)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'To measure Daily functional skills in elderly only in 65-year or order patients.'}, {'measure': 'Medical cost in KRW/person/month', 'timeFrame': '3 months, 6 months', 'description': 'Direct medical cost will be collected through National Health Insurance Corporation and Indirect cost will be collected by caregiver\'s questionnaire. In addition, "EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)" tool will be included in the patient\'s questionnaire to measure the condition of patients at the same time.'}, {'measure': 'Utilization of healthcare services', 'timeFrame': '3 months, 6 months', 'description': 'In order to analyze the cost effectiveness, investigate the frequency of use of early palliative care programs, the use of life-sustaining treatment and hospicee, and the use of complementary and alternative medicine(CAM). CAM include Chinese medicine, aromatherapy, diet, and yoga, etc.'}, {'measure': 'Preference of Advance care and Palliative care', 'timeFrame': '3 months, 6 months', 'description': "to assess the patient's awareness of advanced care planning and willingness to construct advanced care planning. The preference for palliative care is divided according to the life expectancy. Investigate the preference of palliative care in each case - if the life expectancy is within a year, within a few months, or within a few weeks."}, {'measure': 'Mcgill Quality of Life (MQOL)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'To measure mental, social, spiritual quality of life of both patients and caregivers'}, {'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '"Pediatric Quality of Life Inventory(Peds QL)" will be used as assessment tool for QOL among pediatric patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative Care', 'Quality of Life', 'Prospective Cohort Study', 'Treatment decision', 'Utilization of health care'], 'conditions': ['Stage IV Breast Cancer', 'Stage IV Pancreatic Cancer', 'Stage IV Colon Cancer', 'Stage IV Gastric Cancer', 'Stage IV Lung Cancer', 'Stage IV Liver Cancer', 'Malignant Hematologic Neoplasm', 'Biliary Cancer Metastatic', 'Pediatric Leukemia', 'Pediatric Lymphoma', 'Pediatric Brain Tumor', 'Pediatric Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '39582048', 'type': 'DERIVED', 'citation': 'Yun JY, Jung JY, Keam B, Lee NR, Kang JH, Kim YJ, Shim HJ, Jung KH, Koh SJ, Ryu H, Yoo SH, Kang E, Yun YH. Depression, performance status, and discontinued treatment mediate an association of curability belief with prognosis in advanced cancer patients. Sci Rep. 2024 Nov 24;14(1):29098. doi: 10.1038/s41598-024-80687-6.'}]}, 'descriptionModule': {'briefSummary': "This study evaluates the change of quality of life, treatment decision and utilization of health care depending on the use of palliative care in advanced cancer patients by a prospective cohort study. Participants will be separated into different groups by their intentions for using palliative care. Every participant will carry out the questionnaire per 3 months. This cohort study will be ended a year after each participant enrolls. However, if the participant didn't survive during this study, the caregivers will be asked to fill out additional questionnaire after 3 months of the death.", 'detailedDescription': "Patients with advanced cancer report physical, emotional, social and economic problems that may be due to the cancer itself or its treatment. Previous studies have shown the benefit of early palliative care in oncology. However, many Korean patients tend to start palliative care late even in general hospital. Because of the late start of palliative care, the burden of medical expenses increases, on the other hand, the quality of life of terminally ill patients decrease.\n\nIn this study, the use of palliative care in advanced cancer patients will be evaluated by a prospective cohort study. The goals of this study are as follow:\n\nFirst, the clinical, psycho-social, and cognitive factors affecting quality of life, decision making, and hospital utilization (palliative medical team medical treatment, hospice and medical care) of patients with advanced stage cancer will be investigated.\n\nSecond, this study will explore the effects of age-specific characteristics on quality of life and care.\n\nThird, an index, which reflects age-specific characteristics and predicts the time and content of terminal care will be developed. Improvements on the quality of life and care of patients with advanced stage of cancer or metastatic cancer are expected to establish effective terminal care strategies through this study.\n\nThe patients' symptom and quality of life, choice of medical care, advance care planning and caregiver's burden of care will be evaluated every 3 months after confirming the willingness to use palliative care for cancer patients. 3 months after the death, a caregiver evaluation will be conducted and hospice use, medical expenses will be analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced stage of cancer (19 years older) and their families at 14 hospitals nationwide in South Korea', 'healthyVolunteers': False, 'eligibilityCriteria': '\\[Adult Patients\\]\n\nInclusion Criteria:\n\n* 19 years of age or older and diagnosed as cancer older than 19 years of age\n* Stage 4 of advanced Breast Cancer, Colon cancer, gastric cancer, pancreatobiliary cancer, lung cancer, Liver Cancer or Malignant hematologic neoplasm\n* Patients under one of the following status : 1) under the standard chemotherapy, 2) interrupted state of standard chemotherapy, 3) under the additional chemotherapy after standard chemotherapy, 4) terminating state of any chemotherapy yet expected to be survive more than 6 months.\n* who understand the purpose and method of the study and sign with informed consent form.\n\nExclusion Criteria:\n\n* who are unable to participate due to poor cognitive capacity\n* who cannot read or understand Korean language\n* who are unable to complete surveys due to physical conditions\n\n\\[Pediatric Patients\\]\n\nInclusion Criteria:\n\n* Who was diagnosed as pediatric cancer between 0-18 years of age.\n* Younger than 30 years of age\n* Patients under one of the following status : 1)recurrence after 2nd standard chemotherapy or without remission in leukemia, 2) recurrence after stem cell transplantation, 3) diagnosed as the cancer of poor prognosis : ATRT, glioblastoma multiforme, brainstem glioma etc.\n* Patients or their proxy understand the purpose and method of the study and sign with informed consent form.\n\nExclusion Criteria:\n\n* Parents of patient are unable to participate due to poor cognitive capacity\n* Parents of patient do not have legal responsibility or rights of the patient\n* Parents of patients cannot speak, read or understand Korean language'}, 'identificationModule': {'nctId': 'NCT03222258', 'briefTitle': 'Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Change of Quality of Life, Treatment Decision and Utilization of Health Care Depending on the Use of Palliative Care in Adult and Pediatric Patients With Advanced Stage of Cancer: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'HC15C1391-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early palliative care for adult', 'description': 'Being referred to palliative care team before totally terminating their chemotherapy among adult participants.', 'interventionNames': ['Behavioral: Early palliative care', 'Behavioral: Routine hospice care']}, {'label': 'Routine hospice care for adult', 'description': 'Being referred to palliative care team when their last chemotherapy is ended among adult participants.', 'interventionNames': ['Behavioral: Routine hospice care']}, {'label': 'Unused palliative care for adult', 'description': "haven't been under the palliative care among adult participants"}, {'label': 'Palliative care for pediatrics', 'description': 'receiving the palliative care among pediatric participants', 'interventionNames': ['Behavioral: Early palliative care', 'Behavioral: Routine hospice care']}, {'label': 'Unused palliative care for pediatrics', 'description': "haven't received the palliative care among pediatric participants"}], 'interventions': [{'name': 'Early palliative care', 'type': 'BEHAVIORAL', 'description': 'Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.', 'armGroupLabels': ['Early palliative care for adult', 'Palliative care for pediatrics']}, {'name': 'Routine hospice care', 'type': 'BEHAVIORAL', 'description': "Palliative Care Team provide a routine hospice care the same as other patients who doesn't participate this study after the chemotherapy is totally terminated", 'armGroupLabels': ['Early palliative care for adult', 'Palliative care for pediatrics', 'Routine hospice care for adult']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center, Korea', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '52727', 'city': 'Jinju', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '58128', 'city': 'Hwasun', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '41199', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Fatima Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyunghee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05355', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07985', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Young Ho Yun, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}, {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, {'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, {'name': 'Daegu Fatima Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'National Evidence-Based Healthcare Collaborating Agency', 'class': 'OTHER_GOV'}, {'name': 'National Institute of Health, Korea', 'class': 'OTHER_GOV'}, {'name': 'National Clinical Research Coordination Center, Seoul, Korea', 'class': 'OTHER_GOV'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Young Ho Yun', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}