Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-28 @ 6:32 PM
Study NCT ID:
NCT05611450
Status:
UNKNOWN
Last Update Posted:
2022-11-10
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire', 'timeFrame': 'change from baseline at 1 month', 'description': "assessing participants' quality of life"}, {'measure': 'European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire', 'timeFrame': 'change from baseline at 3 month', 'description': "assessing participants' quality of life"}, {'measure': 'European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire', 'timeFrame': 'change from baseline at 6 month', 'description': "assessing participants' quality of life"}, {'measure': 'European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire', 'timeFrame': 'change from baseline at 9 month', 'description': "assessing participants' quality of life"}, {'measure': 'NCI-CTCAE (ver 5.0) guideline', 'timeFrame': 'change from baseline at 1 month', 'description': "assessing participants' skin toxicity grade"}, {'measure': 'NCI-CTCAE (ver 5.0) guideline', 'timeFrame': 'change from baseline at 3 month', 'description': "assessing participants' skin toxicity grade"}, {'measure': 'NCI-CTCAE (ver 5.0) guideline', 'timeFrame': 'change from baseline at 6 month', 'description': "assessing participants' skin toxicity grade"}, {'measure': 'NCI-CTCAE (ver 5.0) guideline', 'timeFrame': 'change from baseline at 9 month', 'description': "assessing participants' skin toxicity grade"}], 'secondaryOutcomes': [{'measure': 'knowledge and skills with disease self-management questionnaire', 'timeFrame': 'change from baseline at 1 month', 'description': "assessing participants' knowledge and skill ability with disease self-management"}, {'measure': 'knowledge and skills with disease self-management questionnaire', 'timeFrame': 'change from baseline at 3 month', 'description': "assessing participants' knowledge and skill ability with disease self-management"}, {'measure': 'knowledge and skills with disease self-management questionnaire', 'timeFrame': 'change from baseline at 6 month', 'description': "assessing participants' knowledge and skill ability with disease self-management"}, {'measure': 'knowledge and skills with disease self-management questionnaire', 'timeFrame': 'change from baseline at 9 month', 'description': "assessing participants' knowledge and skill ability with disease self-management"}, {'measure': 'disease self-efficacy questionnaire', 'timeFrame': 'change from baseline at 1 month', 'description': "assessing participants' self-efficacy with disease self-management"}, {'measure': 'disease self-efficacy questionnaire', 'timeFrame': 'change from baseline at 3 month', 'description': "assessing participants' self-efficacy with disease self-management"}, {'measure': 'disease self-efficacy questionnaire', 'timeFrame': 'change from baseline at 6 month', 'description': "assessing participants' self-efficacy with disease self-management"}, {'measure': 'disease self-efficacy questionnaire', 'timeFrame': 'change from baseline at 9 month', 'description': "assessing participants' self-efficacy with disease self-management"}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'change from baseline at 1 month', 'description': "assessing participants' anxiety and depression"}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'change from baseline at 3 month', 'description': "assessing participants' anxiety and depression"}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'change from baseline at 6 month', 'description': "assessing participants' anxiety and depression"}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'change from baseline at 9 month', 'description': "assessing participants' anxiety and depression"}, {'measure': 'Medical Outcomes Study-Social Support Survey', 'timeFrame': 'chang from baseline at 1 month', 'description': "assessing participants' social support"}, {'measure': 'Medical Outcomes Study-Social Support Survey', 'timeFrame': 'chang from baseline at 3 month', 'description': "assessing participants' social support"}, {'measure': 'Medical Outcomes Study-Social Support Survey', 'timeFrame': 'chang from baseline at 6 month', 'description': "assessing participants' social support"}, {'measure': 'Medical Outcomes Study-Social Support Survey', 'timeFrame': 'chang from baseline at 9 month', 'description': "assessing participants' social support"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disease self-management', 'mobile application', 'target therapy'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': "The study's purpose is to understand the self-management needs of patients with NSCLC receiving targeted therapy, develop a disease self- management application (mHealth Application), and explore the effect of mHealth application on the self-efficacy and health status of patients receiving targeted therapy for NSCLC.\n\nThis study adopts a two-group (pre-and-post-test) design experiment. This study is being conducted over a period of 3 years and is divided in two stages. This study enrolled patients with NSCLC in the outpatient clinic and ward of the Division of Chest Medicine in a northern medical center as the research participants. Stage 1 develop a disease self-management application and understands participants' needs by qualitative study. The participants are a purposive sample of 15-20 patients. Data discontinued when theme saturation is achieved. Stage 2 adopted convenient sampling to enroll 108 patients (54 in the experimental group and 54 in the control group) to evaluate the effectiveness of the disease self-management application. After participant's consent was obtained, this study performed the pre-test and randomized the participants. The experimental group received both routine care and the disease self-management App, while the control group received routine care and part of application. This study collected data before the patients received targeted therapy and in months 1, 3, 6, and 9 after treatment initiation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≧20 years of age\n* diagnosed with advanced NSCLC\n* were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive\n\nExclusion Criteria:\n\n* had received other anti-cancer therapy\n* were difficulty with verbal expression or cognitive dysfunction'}, 'identificationModule': {'nctId': 'NCT05611450', 'briefTitle': 'Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Developing and Testing a Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy: A Mixed-Methods Study', 'orgStudyIdInfo': {'id': '202100777B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'routine care', 'interventionNames': ['Other: disease self-management application']}, {'type': 'EXPERIMENTAL', 'label': 'lung cancer self-management', 'interventionNames': ['Other: disease self-management application']}], 'interventions': [{'name': 'disease self-management application', 'type': 'OTHER', 'description': 'The mHealth application provide disease self-management knowledge and skills and also has the functions of level of skin toxicity warning, uploading photos of skin toxicity, and interacting with healthcare professionals.', 'armGroupLabels': ['lung cancer self-management', 'routine care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kang Hua Chen, PhD', 'role': 'CONTACT', 'email': 'khc@mail.cgu.edu.tw', 'phone': '+886-2118800', 'phoneExt': '5211'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kang Hua Chen', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}