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Breast CancerNCT05921331

RJBC-APP and Breast Cancer Treatment Compliance

A study testing The RJBC-APP and Routine post-surgical follow-up in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
The RJBC-APP and Routine post-surgical follow-up
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteChina
Study dates
10 Oct 2023to 15 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Distant metastases at diagnosis
  • Unable to use a smartphone

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiaosong Chen

    Shanghai, Please Select, 200025

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
The RJBC-APP, Routine post-surgical follow-up
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The RJBC-APPDevice

    Also called RJBC Full-Course Management 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.

  • Routine post-surgical follow-upOther

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

Study groups in NCT05921331
Study groupRoleWhat they receive
The RJBC-APP groupExperimentalParticipants 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.
Receives: Device: The RJBC-APP; Other: Routine post-surgical follow-up
The Control groupActive comparatorParticipants randomized to the Control group have no access to the RJBC-APP and post-surgical follow-up can only be conducted in outpatient clinic.
Receives: Other: Routine post-surgical follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months after adjuvant therapy

  2. Overall Survival (OS)

    OS is calculated from the date of surgery to the date of death.

    Measured: 60 months after adjuvant therapy

Secondary outcomes (4)

  1. 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.

    Measured: 3、6 and 24 months after adjuvant therapy

  2. 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.

    Measured: 3、6、12 and 24 months after adjuvant therapy

  3. 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.

    Measured: 3、6、12 and 24 months after adjuvant therapy

  4. 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.

    Measured: 60 months after adjuvant therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start10 Oct 2023
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921331
Sponsor's protocol ID
RJBC-APP
Status last verified
Sep 2025
First submitted
2 May 2023
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhu S, Li S, Qu R, Ren W, Hu C, Chen X. Association of mobile application information on multidisciplinary therapy and treatment compliance in early-stage breast cancer: A prospective multicenter randomized phase III study. Breast. 2026 Aug;88:104811. doi: 10.1016/j.breast.2026.104811. Epub 2026 May 14.

    PubMed 42150214

Questions about this trial

What is this clinical trial studying?

A study testing The RJBC-APP and Routine post-surgical follow-up in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of compliance with adjuvant therapy (time frame: 12 months after adjuvant therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05921331, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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