Breast Cancer Clinical Trial
Official title:
Mobile Medical Application on Adjuvant Therapy Compliance and Quality of Life in Patients With Early Breast Cancer: a Multicentric, Open-labeled, Randomized Controlled Trial
The goal of this multicentric randomized controlled clinical trial is to test the role of mobile medical application (APP) on adjuvant therapy compliance and quality of life (QoL) in patients with early breast cancer. Participants assigned to the Ruijin Breast Cancer APP (RJBC-APP) group can receive treatment reminders, matters needing attention as well as science knowledge and they can communicate with the medical staff during adjuvant treatments while follow-up can only be conducted in outpatient clinic for those in the Control group.
Status | Not yet recruiting |
Enrollment | 490 |
Est. completion date | August 1, 2026 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Females aged 18-70 2. Eastern Cooperative Oncology Group Performance Status Score 0-2 3. Breast cancer by pathology 4. Adjuvant therapy by multidisciplinary team 5. Written informed consent form Exclusion Criteria: 1. Distant metastases at diagnosis 2. Unable to use a smartphone |
Country | Name | City | State |
---|---|---|---|
China | Xiaosong Chen | Shanghai | Please Select |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of compliance with adjuvant therapy | Compliance is defined as completing the adjuvant therapy recommended by multidisciplinary team in terms of the type, dosage, date and course, and non-compliance is considered in the presence of any of the following cases: 1) the patient refuses to accept the recommended treatments, 2) the actual treatments are different from those recommended, 3) the patient dose not complete the full course of treatments, 4) the patient starts the treatment 7 days or more later than the established date, 5) the patient does not follow the recommended dose and intensity. | 12 months after adjuvant therapy | |
Primary | Overall Survival (OS) | OS is calculated from the date of surgery to the date of death. | 60 months after adjuvant therapy | |
Secondary | Rate of compliance with adjuvant therapy | Compliance is defined as completing the adjuvant therapy recommended by multidisciplinary team in terms of the type, dosage, date and course, and non-compliance is considered in the presence of any of the following cases: 1) the patient refuses to accept the recommended treatments, 2) the actual treatments are different from those recommended, 3) the patient dose not complete the full course of treatments, 4) the patient starts the treatment 7 days or more later than the established date, 5) the patient does not follow the recommended dose and intensity. | 3?6 and 24 months after adjuvant therapy | |
Secondary | Quality of Life (QoL) Scale | The QoL Scale is evaluated by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0). The questionnaire is composed of 30 items among which items 1-28 are divided into 4 levels (scored as 1-4 respectively, higher scores mean a worse outcome) and items 29-30 are divided into 7 grades (scored as 1-7 respectively, higher scores mean a better score). The items are further divided into 15 domains. The standard score (0-100) is calculated from raw score of each domain and higher scores mean a better outcome. | 3?6?12 and 24 months after adjuvant therapy | |
Secondary | Cancer-related symptoms scores | Cancer-related symptoms are evaluated by the MD Anderson Symptom Inventory (MDASI). The questionnaire is composed of 19 items among which items 1-13 are degree of 13 common symptoms and items 14-19 are degrees of the impact on daily life (scored as 1-10 respectively, higher scores mean a better score). The total score (0-190) is calculated by sum of each item and higher scores mean a worse outcome. | 3?6?12 and 24 months after adjuvant therapy | |
Secondary | Disease-free Survival (DFS) | DFS is calculated from the date of surgery to the first date of the following events: local recurrence, regional recurrence, distant metastasis, contralateral breast cancer, secondary primary malignancy and death. | 60 months after adjuvant therapy |
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