Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-31 @ 1:12 PM
Study NCT ID:
NCT05258461
Status:
UNKNOWN
Last Update Posted:
2022-02-28
First Post:
2022-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Login times', 'timeFrame': 'Documented automatically by the application every two weeks', 'description': 'Login times to the application during chemotherapy'}, {'measure': 'Average time spent on the application', 'timeFrame': 'Documented automatically by the application every two weeks', 'description': 'Average time spent on the application each time'}, {'measure': 'Questions addressed on the Q&A platform', 'timeFrame': 'Documented automatically by the application every two weeks', 'description': 'Questions addressed on the Q\\&A platform'}], 'primaryOutcomes': [{'measure': 'Change from baseline quality of life scores at 4 months', 'timeFrame': '1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)', 'description': 'Quality of life scores will be assessed using the simplified Chinese version of the Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3).'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of 12 common adverse events', 'timeFrame': '4 months after the first cycle (each cycle is 21 days)', 'description': 'The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Application', 'Adverse Event', 'Quality of Life', 'Chemotherapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21513533', 'type': 'BACKGROUND', 'citation': 'Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56.'}, {'pmid': '18653703', 'type': 'BACKGROUND', 'citation': 'Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1007/978-3-211-89836-9_1474', 'label': 'WHO-toxicity scale'}, {'url': 'https://tbcr.amegroups.com/article/view/45555', 'label': 'Guidelines of Chinese Society of Clinical Oncology (CSCO) on Diagnosis and Treatment of Breast Cancer (2020 version)'}, {'url': 'https://www.nccn.org/', 'label': '(NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer, Version 1.2022'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathological diagnosis of invasive breast cancer\n2. breast surgery within the past 2-8 weeks\n3. adult female\n4. must be able to use mobile phones\n5. speak and write Chinese fluently to sign the informed consent\n\nExclusion Criteria:\n\n1. severe comorbidity that interferes with outcome evaluation\n2. insufficient Chinese language skills\n3. inability to use mobile phones\n4. cognitive disability to give informed consent'}, 'identificationModule': {'nctId': 'NCT05258461', 'briefTitle': 'An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Smart'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The intervention group', 'description': 'The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.', 'interventionNames': ['Other: use of a smartphone app for adverse event management', 'Other: conventional adverse event management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': "The control group will receive conventional adverse event management during chemotherapy. Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.", 'interventionNames': ['Other: conventional adverse event management']}], 'interventions': [{'name': 'use of a smartphone app for adverse event management', 'type': 'OTHER', 'description': 'At their enrollment, patients will receive detailed introduction and adequate assistance on the use of the smartphone app. The smartphone app will offer proper advice for adverse event management based on calculated results by artificial intelligence on the innovative app, which was developed by YL et al. It was specifically intended for risk prediction, early prevention, as well as management of symptoms and concerns during adjuvant chemotherapy in the treatment of breast cancer. The app consisted of 4 modules: (1) Module 1: clinical data collection. (2) Module 2: risk evaluation for 12 common adverse events during breast cancer chemotherapy. (3) Module 3: personalized prophylaxis based on predicted risks of adverse events. (4) Module 4: Q\\&A platform.', 'armGroupLabels': ['The intervention group']}, {'name': 'conventional adverse event management', 'type': 'OTHER', 'description': "Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience. For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals. 5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.", 'armGroupLabels': ['The control group', 'The intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yan Li, Doctor', 'role': 'CONTACT', 'email': 'liyan0551@163.com', 'phone': '+86 17600352101'}], 'overallOfficials': [{'name': 'Yan Li, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will not become available to public.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}