Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 1:35 PM
Study NCT ID:
NCT01043068
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2010-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in pain scores', 'timeFrame': 'Jan 2010 - October 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer pain', 'opioid', 'guideline'], 'conditions': ['Cancers, Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (VAS; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment\n* A minimum age of 18 years\n\nExclusion Criteria:\n\n* Opioid intolerance\n* No longer treatment for their underlying disease.\n* Intracerebral primary or metastatic lesion\n* Impaired sensory or cognitive function\n* Pregnant or lactating woman\n* Women of child bearing potential not using a contraceptive method\n* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential\n* Any patients judged by the investigator to be unfit to participate in the study'}, 'identificationModule': {'nctId': 'NCT01043068', 'briefTitle': 'The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients', 'orgStudyIdInfo': {'id': 'CAPAM-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain control', 'description': 'Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.', 'interventionNames': ['Drug: Cancer pain management']}], 'interventions': [{'name': 'Cancer pain management', 'type': 'DRUG', 'description': 'Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.', 'armGroupLabels': ['Pain control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Dae Hyun Kim, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sang Myung Woo', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}