Breast (Edinburgh, Scotland) · 2026
Association of mobile application information on multidisciplinary therapy and treatment compliance in early-stage breast cancer: A prospective multicenter randomized phase III study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Zhu Siji, Li Shuai, Qu Rui, Ren Weili, Hu Chao, Chen Xiaosong
Аннотация
BACKGROUND: Multidisciplinary therapy (MDT) can improve early breast cancer outcome, while its treatment completion rate is critical. This study aimed to evaluate the association of a mobile health application (RJBC-APP) information on MDT and its treatment adherence, compared with standard clinical management.
METHODS: The RJBC-APP study is a prospective, multicenter, randomized, phase 3 clinical trial that enrolled patients with early-stage breast cancer after MDT for adjuvant treatment. Eligible patients were randomized at a 1:1 ratio into two groups: the RJBC-APP group (the mobile-based App) and the control group. The primary endpoint was 12-month adjuvant treatment compliance rate. Secondary endpoints included treatment adherence rates at 3, 6, and 24 months.
RESULTS: Between October 2023 and July 2024, a total of 508 patients were randomized, and 496 were included in the final analysis (249 [50.2%] in the RJBC-APP group and 247 [49.8%] in the control group). The 12-month treatment compliance rate was 85.5% (95% confidence interval [CI]: 81.1%-90.0%) in the RJBC-APP group and 81.4% (95% CI: 76.5%-86.3%) in the control group (P = 0.212). Exploratory subgroup analysis revealed that RJBC-APP usage was associated with a higher treatment completion rate in patients aged ≤50 years (85.0% vs. 78.2%), whereas no comparable effect in older patients (86.2% vs. 86.0%) (P for interaction = 0.043). Additionally, the RJBC-APP improved the 3-month treatment completion rate compared with control group (93.2% vs. 87.0%, P = 0.022).
CONCLUSIONS: The RJBC-APP did not improve 12-month adjuvant therapy compliance rate for early-stage breast cancer patients receiving MDT. While exploratory subgroup analysis indicated a potential benefit of the RJBC-APP on compliance in younger patients or in the short-term period, these should be considered as hypothesis-generating and warrant further investigation.
TRIAL REGISTRATION: cinicalTrials.gov Identifier: NCT05921331.
METHODS: The RJBC-APP study is a prospective, multicenter, randomized, phase 3 clinical trial that enrolled patients with early-stage breast cancer after MDT for adjuvant treatment. Eligible patients were randomized at a 1:1 ratio into two groups: the RJBC-APP group (the mobile-based App) and the control group. The primary endpoint was 12-month adjuvant treatment compliance rate. Secondary endpoints included treatment adherence rates at 3, 6, and 24 months.
RESULTS: Between October 2023 and July 2024, a total of 508 patients were randomized, and 496 were included in the final analysis (249 [50.2%] in the RJBC-APP group and 247 [49.8%] in the control group). The 12-month treatment compliance rate was 85.5% (95% confidence interval [CI]: 81.1%-90.0%) in the RJBC-APP group and 81.4% (95% CI: 76.5%-86.3%) in the control group (P = 0.212). Exploratory subgroup analysis revealed that RJBC-APP usage was associated with a higher treatment completion rate in patients aged ≤50 years (85.0% vs. 78.2%), whereas no comparable effect in older patients (86.2% vs. 86.0%) (P for interaction = 0.043). Additionally, the RJBC-APP improved the 3-month treatment completion rate compared with control group (93.2% vs. 87.0%, P = 0.022).
CONCLUSIONS: The RJBC-APP did not improve 12-month adjuvant therapy compliance rate for early-stage breast cancer patients receiving MDT. While exploratory subgroup analysis indicated a potential benefit of the RJBC-APP on compliance in younger patients or in the short-term period, these should be considered as hypothesis-generating and warrant further investigation.
TRIAL REGISTRATION: cinicalTrials.gov Identifier: NCT05921331.