RJBC-APP and Breast Cancer Treatment Compliance

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: Breast Cancer
• Intervention / Treatment: Device: The RJBC-APP; Other: Routine post-surgical follow-up

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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)	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	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	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	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)	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

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Xiaosong Chen, Professor, Xiaosong Chen

Study record dates

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: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• 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