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Trial Title:
RJBC-APP and Breast Cancer Treatment Compliance
NCT ID:
NCT05921331
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
The RJBC-APP
Description:
The RJBC-APP consists of the following features: 1. Login, logout, setting, and
modification of personal information. 2. Full-course management included registering for
information on the surgical treatment, viewing the results of the multidisciplinary team
(MDT) discussion, generating the treatment process according to the MDT discussion,
receiving the reminder of the treatment, confirming the completion of the treatment,
filling in the follow-up information, and consulting a specialist nurse. 3. Questionnaire
and feedback.
Arm group label:
The RJBC-APP group
Other name:
RJBC Full-Course Management APP
Intervention type:
Other
Intervention name:
Routine post-surgical follow-up
Description:
The routine post-surgical follow-up is conducted in the outpatient clinic.
Arm group label:
The Control group
Arm group label:
The RJBC-APP group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xiaosong Chen
Address:
City:
Shanghai
Zip:
200025
Country:
China
Start date:
October 10, 2023
Completion date:
June 15, 2026
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921331
