An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy
NCT ID: NCT05258461
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2022-03-07
2022-12-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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The intervention group
The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
use of a smartphone app for adverse event management
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.
conventional adverse event management
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.
The control group
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.
conventional adverse event management
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.
Interventions
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use of a smartphone app for adverse event management
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.
conventional adverse event management
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.
Eligibility Criteria
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Inclusion Criteria
2. breast surgery within the past 2-8 weeks
3. adult female
4. must be able to use mobile phones
5. speak and write Chinese fluently to sign the informed consent
Exclusion Criteria
2. insufficient Chinese language skills
3. inability to use mobile phones
4. cognitive disability to give informed consent
18 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Yan Li, Doctor
Role: STUDY_DIRECTOR
Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Central Contacts
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References
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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.
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.
Related Links
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WHO-toxicity scale
Guidelines of Chinese Society of Clinical Oncology (CSCO) on Diagnosis and Treatment of Breast Cancer (2020 version)
(NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer, Version 1.2022
Other Identifiers
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Smart
Identifier Type: -
Identifier Source: org_study_id