RJBC-APP and Breast Cancer Treatment Compliance

September 28, 2025 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Please Select
      • Shanghai, Please Select, China, 200025
        • Xiaosong Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The RJBC-APP group
Participants randomized to the RJBC-APP group should register on the RJBC-APP, through which they can receive treatment reminders, matters needing attention as well as science knowledge and communicate with the medical staff.
Device: The RJBC-APP
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.
Other Names:
  • RJBC Full-Course Management APP
Other: Routine post-surgical follow-up
The routine post-surgical follow-up is conducted in the outpatient clinic.
Active Comparator: The Control group
Participants randomized to the Control group have no access to the RJBC-APP and post-surgical follow-up can only be conducted in outpatient clinic.
Other: Routine post-surgical follow-up
The routine post-surgical follow-up is conducted in the outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after adjuvant therapy
Overall Survival (OS)
Time Frame: 60 months after adjuvant therapy
OS is calculated from the date of surgery to the date of death.
60 months after adjuvant therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of compliance with adjuvant therapy
Time Frame: 3、6 and 24 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.
3、6 and 24 months after adjuvant therapy
Quality of Life (QoL) Scale
Time Frame: 3、6、12 and 24 months after adjuvant therapy
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
Cancer-related symptoms scores
Time Frame: 3、6、12 and 24 months after adjuvant therapy
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
Disease-free Survival (DFS)
Time Frame: 60 months after adjuvant therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xiaosong Chen, Professor, Xiaosong Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 28, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC-APP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe