A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane. The main objective of the study is to evaluate medication adherence in postmenopausal, hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy, with focus on the patient perspective, will be investigated: * Patient satisfaction with treatment information * Patient satisfaction with treatment * Health-related quality of life * Treatment efficacy * Treatment-related toxicity * Patient follow-up by the oncologic team/general practitioner and or specialized home nurses This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.
Study Type
OBSERVATIONAL
Enrollment
100
Katholieke Universiteit Leuven - Clinical Pharmacology and Pharmacotherapeutics
Leuven, Brabant, Belgium
RECRUITINGMedication adherence
At the first visit patients will receive their anti-cancer medication by the hospital in two separate pill boxes which electronically record openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in these chips will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.
Time frame: one year
Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire at the start of the treatment and after approximately 1, 3, 6 and 12 months of treatment
Time frame: one year
Morisky Medication Adherence Scale (MMAS)
Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment.
Time frame: one year
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3, 6 and 12 months of treatment.
Time frame: one year
Functional Assessment of Cancer Therapy - for patients with breast cancer (FACT-B)
Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment and after approximately 1, 3, 6 and 12 months of treatment.
Time frame: one year
Tumor status evaluation
Tumor status evaluation of the patient will be assessed by the treating oncologist by CA15-3 \& CEA markers at the start of the study and after 1, 3, 6 and 12 months of treatment.
Time frame: one year
Tumor status evaluation
Tumor status evaluation of the patient will be assessed by the treating oncologist by RECIST criteria after 1, 3, 6 and 12 months of treatment.
Time frame: one year
Performance status of the patient
Performance status of the patient will be assessed by the treating oncologist by ECOG criteria at the start of the study and after 1, 3, 6 and 12 months of treatment.
Time frame: one year
Toxicity of treatment
Severity of adverse events and relation to the treatment will be assessed by the treating oncologist, based on CTC-NCI 4.0, after 1, 3, 6 and 12 months of treatment.
Time frame: one year
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