Mobile Medical Application on Adjuvant Therapy Compliance and Quality of Life in Patients With Early Breast Cancer: a Multicentric, Open-labeled, Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- Rate of compliance with adjuvant therapy
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
Adjuvant treatments has significantly improved the prognosis of early breast cancer patients. However, previous studies suggested the existence of noncompliance to adjuvant therapies, which might cause detriments to disease outcomes. 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. Patients diagnosed with invasive breast cancers after surgery will be randomly assigned to the Ruijin Breast Cancer APP (RJBC-APP) group or the Control group. Those in the 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. The primary endpoint is the rate of adjuvant therapy compliance at 12 months after randomization. Secondary endpoints consist of compliance rates at 3, 6, 24 months after randomization, QoL and cancer-related symptoms scores at 3, 6, 12, 24 months, disease-free survival (DFS) and overall survival (OS) at 60 months.
Investigators
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Females aged 18-70
- •Eastern Cooperative Oncology Group Performance Status Score 0-2
- •Breast cancer by pathology
- •Adjuvant therapy by multidisciplinary team
- •Written informed consent form
Exclusion Criteria
- •Distant metastases at diagnosis
- •Unable to use a smartphone
Outcomes
Primary Outcomes
Rate of compliance with adjuvant therapy
Time Frame: 12 months after 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.
Overall Survival (OS)
Time Frame: 60 months after adjuvant therapy
OS is calculated from the date of surgery to the date of death.
Secondary Outcomes
- Rate of compliance with adjuvant therapy(3、6 and 24 months after adjuvant therapy)
- Quality of Life (QoL) Scale(3、6、12 and 24 months after adjuvant therapy)
- Cancer-related symptoms scores(3、6、12 and 24 months after adjuvant therapy)
- Disease-free Survival (DFS)(60 months after adjuvant therapy)