Breast Cancer
Conditions
Keywords
Breast cancer
Brief summary
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.
Interventions
DRUGRibociclib
CDK4/6 inhibitor
DRUGLetrozole
Aromatase inhibitor
DRUGAnastrozole
Aromatase inhibitor
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer; 2. Age ≥ 18 at the time of initiation of ribociclib therapy; 3. Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent; 4. It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib; 5. Provision of written informed consent.
Exclusion criteria
1. Patients participating in any interventional clinical study at the time of signing the informed consent; 2. Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period | 12 months | The difference between the two groups (App and non-App) in number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (excluding patients who discontinued treatment due to AE, disease relapse, or death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of sessions using the web application per month | Month 1 - Month 36 | To describe the rate of the web application usage in the group of patients who use the web application. |
| Total duration of sessions (in minutes) per month | Month 1 - Month 36 | To describe the rate of the web application usage in the group of patients who use the web application. |
| Number of questions to the chatbot per month | Month 1 - Month 36 | To describe the rate of the web application usage in the group of patients who use the web application. |
| Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS) | Month 1, 3, 6, 12, 24, 36 | Evaluation of patient satisfaction with the application on a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36 |
| Evaluation of oncologist satisfaction with the application according to a 0-10 VAS | Month 1, 3, 6, 12, 24, 36 | Evaluation of oncologist satisfaction with the application according to a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36 |
| Number of patients in each response category according to the questionnaire on quality of life | Month 1, 3, 6, 12, 24, 36 | The number (%) of patients in each response category (no problems, mild problems, moderate problems, severe problems, and extremely severe problems) according to the questionnaire scale (mobility, self-care, normal activities, pain/discomfort, anxiety/depression) in M1, M3, M6, M12, M24, M36 in the groups using and not using the web application |
| VAS score according to the questionnaire on quality of life | Month 1, 3, 6, 12, 24, 36 | VAS score according to the questionnaire (VAS 0-100, where 0 is the worst health state and 100 is the best health state) at M1, M3, M6, M12, M24, and M36 in both app user and non-app user groups |
| Assessment of patient satisfaction with treatment | Month 3, 6, 12, 24, 36 | Assessment of patient satisfaction with treatment (VAS 0-10, where 0 is completely dissatisfied, and 10 is completely satisfied) at M3, M6, M12, M24, and M36 in both app user and non-app user groups |
| Dose intensity | Month 3, 6, 12, 24, 36 | Dose intensity (% of missed doses as assessed by the patient, except for therapy suspension due to AE) at M3, M6, M12, M24, and M36 in both app user and non-app user groups |
| Number of patients with adverse events (AE) | Month 3, 6, 12, 24, 36 | The percentage (%) of patients with AE (cumulative and depending on the severity) at M3, M6, M12, M24, and M36 in both app user and non-app user groups |
| 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 | Month 3, 6, 12, 24, 36 | The percentage (%) of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE at M3, M6, M12, M24, and M36 in both app user and non-app user groups |
| 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 | Baseline | Proportion (%) 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 |
Countries
Russia
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed