ADHEREADherence to ADjuvant HormonE theRapiEs The association between illness perceptions and adherence to endocrine therapies in patients with breast cancer
- Conditions
- This study will include women with stage I-III breast cancer who are scheduled to receive adjuvant ET without adjuvant chemotherapy
- Registration Number
- NL-OMON19944
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
This study will include women with stage I-III breast cancer who are scheduled to receive adjuvant ET without adjuvant chemotherapy. Patients will be recruited from the Leiden University Medical Center in the Netherlands, the Haaglanden Medical Center in the Netherlands and the Saitama Cancer Center in Japan.
To be eligible to participate in this study, a subject must meet all of the following criteria:
•Female patients aged 18 years or older;
•Stage I, II or III HR-positive breast cancer;
•Scheduled adjuvant endocrine therapy.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Patients with M+ tumors;
•Patients receiving neoadjuvant endocrine therapy;
•Patients receiving (neo)adjuvant chemotherapy;
•Patients with other types of active cancer within the past 3 years;
•Previous use of endocrine therapy or chemotherapy;
•Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the predictive value of illness perceptions, fear of cancer recurrence, medication beliefs and quality of life on adherence to endocrine treatment at 12 months
- Secondary Outcome Measures
Name Time Method To study adherence to endocrine therapy at 3 and 6 months.<br>To compare cross-cultural differences of illness perceptions, medication beliefs, quality of life and adherence to ET in women with breast cancer.<br>To determine the ability to retain/resume work.<br>To observe and evaluate occurrence of side effects (grade III/IV).<br>