Study Evaluating the Effect of Standardized Patient Training on Treatment Discontinuation in Breast Cancer Patients

Breast cancer (mammary carcinoma) is considered advanced or metastatic when the cancer has spread beyond the breast to other parts of the body. At these stages, treatment focuses not only on controlling tumor growth but also increasingly on alleviating symptoms and improving quality of life. The choice of therapy depends, among other factors, on the biological characteristics of the tumor. Some forms of breast cancer respond to the hormones estrogen and progesterone by growing, meaning they are hormone-sensitive (hormone receptor-positive). In these cases, anti-hormone therapies are the preferred treatment option, as they specifically target the effects of these hormones. HER2 is a surface protein that can promote tumor growth. This study includes only patients whose tumor cells do not express this protein (HER2-negative). An established medication for HER2-negative, hormone receptor-positive breast cancer is abemaciclib, a CDK4/6 inhibitor that blocks cell growth by interrupting the cell cycle. It is taken orally and is effective in combination with anti-hormone therapies, particularly in patients whose disease has progressed following prior treatments.

The IMPACT study is investigating whether regular, standardized patient coaching provided by specially trained oncology nurses improves patients’ ability to cope with treatment, manage side effects, and avoid treatment interruptions. To this end, study participants are randomly assigned to two groups: one group receives continuous, standardized coaching, while the other group is cared for according to standard practice. In addition, participants in the coaching group can take part in an electronic program for mindfulness-based stress reduction (eMBSR), which is designed to help reduce stress and improve quality of life. Both participants and medical staff know which group they belong to (open-label study design). After 24 weeks, the study will analyze how many participants have interrupted or discontinued therapy and what quality of life they report.

Eligible participants include women and men aged 18 and older with advanced or metastatic hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer who are being treated with abemaciclib. In addition, patients with the same breast cancer characteristics who have previously received anti-hormone therapy combined with fulvestrant or chemotherapy are also eligible to participate.