Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

Обзор

This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.

Вмешательства

• Препарат Ribociclib
  CDK4/6 inhibitor
• Препарат Letrozole
  Aromatase inhibitor
• Препарат Anastrozole
  Aromatase inhibitor

Первичные конечные точки

• Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Number of sessions using the web application per month [Срок оценки: Month 1 - Month 36]
• Total duration of sessions (in minutes) per month [Срок оценки: Month 1 - Month 36]
• Number of questions to the chatbot per month [Срок оценки: Month 1 - Month 36]
• Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS) [Срок оценки: Month 1, 3, 6, 12, 24, 36]
• Evaluation of oncologist satisfaction with the application according to a 0-10 VAS [Срок оценки: Month 1, 3, 6, 12, 24, 36]
• Number of patients in each response category according to the questionnaire on quality of life [Срок оценки: Month 1, 3, 6, 12, 24, 36]
• VAS score according to the questionnaire on quality of life [Срок оценки: Month 1, 3, 6, 12, 24, 36]
• Assessment of patient satisfaction with treatment [Срок оценки: Month 3, 6, 12, 24, 36]
• Dose intensity [Срок оценки: Month 3, 6, 12, 24, 36]
• Number of patients with adverse events (AE) [Срок оценки: Month 3, 6, 12, 24, 36]
• Number of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE [Срок оценки: Month 3, 6, 12, 24, 36]
• Number of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer;
• Age ≥ 18 at the time of initiation of ribociclib therapy;
• Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent;
• It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib;
• Provision of written informed consent.

Критерии исключения

• Patients participating in any interventional clinical study at the time of signing the informed consent;
• Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Россия · 7 центров

• Novartis Investigative Site — Pskov
• Novartis Investigative Site — Moscow
• Novartis Investigative Site — Saint Petersburg
• Novartis Investigative Site — Saint Petersburg
• Novartis Investigative Site — Saint Petersburg
• Novartis Investigative Site — Sestroretsk
• Novartis Investigative Site — Ufa

Идентификаторы

NCT: NCT06905301 · CLEE011O1RU01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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