Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT03439904
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Individualized Pharmaceutical-care in Outpatients With Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-13', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in medication adherence', 'timeFrame': 'Change from baseline at 1 month', 'description': 'The investigators will measure the change in medication adherence via Morisky Scale from baseline to 1 months. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.'}], 'secondaryOutcomes': [{'measure': 'Change in pain score', 'timeFrame': 'Change from baseline pain score at 1 month', 'description': 'Comparison of pain score of cancer pain patients with or without pharmaceutical care. Pain score will be assessed using numeric rating scale (NRS). An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."'}, {'measure': 'Change in quality of life', 'timeFrame': 'Change from baseline quality of life at 1 month', 'description': 'Comparison of quality of life of cancer pain patients with or without pharmaceutical care. Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D). It is a questionnaire to measure quality of life. It contains 5 domains: Mobility; Self-care; Usual activity; Pain; Anxiety/depression. It also contains a visual analogue scale. Weights are used to score the responses to the 5 domains, with scores ranging from 0 to 1 (where a score of 1 represents a perfect state). For the visual analogue scale, participants draw a line from a box to the point on the thermometer-like scale corresponding to their health state, 0-100 (100 = Best health state)'}, {'measure': "Change in patients' knowledge of cancer pain and analgesics", 'timeFrame': 'Change from baseline knowledge at 1 month', 'description': "Comparison of knowledge of cancer pain and analgesics for cancer pain patients with or without pharmaceutical care. Knowledge of pain treatment and analgesics will be assessed using investigator designed questionnaire. This questionnaire consists of 16 items assessing patients' knowledge about cancer pain, treatment of cancer pain and medications for cancer pain. The total score ranges from 0 to 16 with higher score indicating better knowledge."}, {'measure': 'Incidence of adverse events [safety and tolerability]', 'timeFrame': 'Up to 1 month', 'description': 'Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. Number and percentage of subjects who experienced an adverse event in this study is presented.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmaceutical care', 'adherence'], 'conditions': ['Cancer Pain']}, 'referencesModule': {'references': [{'pmid': '36267757', 'type': 'DERIVED', 'citation': 'Ding H, Song Y, Wu N, Zheng X, Wei Q, Sun Y, Xie R, Zhai Q, Xu S, Qi Y, Wang Y, Li H, Yang L, Fan Q, Zhao Q, Chen J, Shi J, Duan C, Du Q, Zhang Y, Song Z, Fu S, Cai Y, Huang X, Fang L, Liu Y, Huang P. Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial. Ann Transl Med. 2022 Sep;10(18):989. doi: 10.21037/atm-22-4091.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients', 'detailedDescription': 'This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older;\n* Histologically confirmed solid tumor;\n* Diagnosed chronic cancer pain;\n* Opioid-tolerant patients;\n* Overall survival is expected to be over 3 months;\n* Karnofsky performance score≥50;\n* Willing and able to comply with the protocol\n\nExclusion Criteria:\n\n* Patients aged 18 years or older;\n* Histologically confirmed solid tumor;\n* Diagnosed chronic cancer pain;\n* Opioid-tolerant patients;\n* Overall survival is expected to be over 3 months;\n* Karnofsky performance score≥50;\n* Willing and able to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT03439904', 'briefTitle': 'Individualized Pharmaceutical-care in Outpatients With Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients', 'orgStudyIdInfo': {'id': 'ECCOPG-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pharmaceutical care intervention group', 'description': 'Patients will receive individualized pharmaceutical care in addition to usual medical care', 'interventionNames': ['Other: Pharmaceutical care']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients will receive usual medical care'}], 'interventions': [{'name': 'Pharmaceutical care', 'type': 'OTHER', 'description': 'Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.', 'armGroupLabels': ['pharmaceutical care intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Huang, Doctor', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ping Huang', 'role': 'CONTACT', 'email': 'huangping1841@zjcc.org.cn', 'phone': '+86-571-88122118'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Pharmacy', 'investigatorFullName': 'Ping Huang', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}