Clinical trial NCT05921331: RJBC-APP and Breast Cancer Treatment Compliance
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Rate of compliance with adjuvant therapy
timeFrame: 12 months after adjuvant therapy
measure: Overall Survival (OS)
timeFrame: 60 months after adjuvant therapy
Secondary outcomes:
measure: Rate of compliance with adjuvant therapy
timeFrame: 3、6 and 24 months after adjuvant therapy
measure: Quality of Life (QoL) Scale
timeFrame: 3、6、12 and 24 months after adjuvant therapy
measure: Cancer-related symptoms scores
timeFrame: 3、6、12 and 24 months after adjuvant therapy
measure: Disease-free Survival (DFS)
timeFrame: 60 months after adjuvant therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaosong Chen
state: Please Select
Study officials:
affiliation: Xiaosong Chen
name: Xiaosong Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: