NCT05921331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

May 2, 2023

Last Update Submit

September 28, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

The RJBC-APP group

EXPERIMENTAL

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-APPOther: Routine post-surgical follow-up

The Control group

ACTIVE COMPARATOR

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

Interventions

The RJBC-APPDEVICE

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.

Also known as: RJBC Full-Course Management APP
The RJBC-APP group
Routine post-surgical follow-upOTHER

The routine post-surgical follow-up is conducted in the outpatient clinic.

The Control groupThe RJBC-APP group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Distant metastases at diagnosis
  • Unable to use a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaosong Chen

Shanghai, Please Select, 200025, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xiaosong Chen, Professor

    Xiaosong Chen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2023

First Posted

June 27, 2023

Study Start

October 10, 2023

Primary Completion

July 15, 2025

Study Completion

July 15, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)