Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-04-21 @ 11:44 AM
Study NCT ID:
NCT02564666
Status:
UNKNOWN
Last Update Posted:
2015-10-01
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2015-08-20', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The satisfaction with Information about Medicines Scale (SIMS) score', 'timeFrame': '6 weeks', 'description': 'SIMS is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib'}], 'primaryOutcomes': [{'measure': 'Drug compliance for patients with HCC who is taking Sorafenib compliance', 'timeFrame': '6 weeks', 'description': '"Drug compliance for patients with HCC who is taking Sorafenib" as Assessed by MMAS-8 Score and compare "MMAS-8 score" between control group and intervention group.\n\nMeasurement is Scores range from 0 \\[high adherence\\] to 3\\~8 \\[low adherence\\] )'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '12 months'}, {'measure': 'Duration of dosing period', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'sorafenib', 'telephone counseling'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects used as systemic treatment in patients with unresectable hepatocellular carcinoma.\n\nAlthough sorafenib has demonstrated many clinical benefits in patients, its adverse cannot be ignores.\n\nThis drug occasionally causes severe adverse events (AEs), which include hand-foot skin reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although most adverse events are reversible, they can significantly impact a patient\'s quality of life and occasionally result in dose reduction or discontinuation of therapy Patients are also more likely to remain on treatment if they are guided over the difficult initial 4\\~6wks of therapy during which time the development of adverse events following sorafenib treatment initiation are most likely to occur.\n\nPatient education, proactive management and establishing and maintaining open communication between patients and the nurse are crucial to the effective management of these adverse events.\n\nThis study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10\\~15 minutes (from a well-trained nurse)\n\nThe purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by "The Satisfaction with information about Medicines Scale(SIMS)" tool.', 'detailedDescription': 'This study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10\\~15 minutes (from a well-trained nurse)\n\nThe purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by "The Satisfaction with information about Medicines Scale(SIMS)" tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who agrees voluntarily\n* Patient with a diagnosis of HCC is receiving Sorafenib monotherapy.\n* Child-Pugh class, A or B, ECOG PS 0\\~2\n* 20 years of age or older.\n* Patient who can listen and speak Korean\n\nExclusion Criteria:\n\n* lack of cognitive ability or any r psychiatric illness\n* Patient who is receiving combination treatment of TACE or other HCC treatment with Sorafenib.\n* A hearing-impaired patient.\n* Patient who has accompanied other primary malignants tumor in other organs except for HCC.'}, 'identificationModule': {'nctId': 'NCT02564666', 'acronym': 'SORATEL', 'briefTitle': 'The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2015-0815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Telephone counseling', 'description': 'regular telephone counseling per week', 'interventionNames': ['Other: telephone counseling']}, {'type': 'NO_INTERVENTION', 'label': 'No telephone counseling', 'description': 'no regular telephone counseling'}], 'interventions': [{'name': 'telephone counseling', 'type': 'OTHER', 'description': 'regular telephone counseling for compliance and advese event', 'armGroupLabels': ['Telephone counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ju Hyun Shim, MD. PhD', 'role': 'CONTACT', 'email': 's5854@medimail.co.kr', 'phone': '82230103190'}, {'name': 'Jin-A Park', 'role': 'CONTACT', 'email': 'pred1054@naver.com', 'phone': '82230101334'}], 'overallOfficials': [{'name': 'Ju Hyun Shim, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Ju Hyun Shim', 'investigatorAffiliation': 'Asan Medical Center'}}}}