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ID
Source
Brief title
Health condition
This study will include women with stage I-III breast cancer who are scheduled to receive adjuvant ET without adjuvant chemotherapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
To study adherence to endocrine therapy at 3 and 6 months.
To compare cross-cultural differences of illness perceptions, medication beliefs, quality of life and adherence to ET in women with breast cancer.
To determine the ability to retain/resume work.
To observe and evaluate occurrence of side effects (grade III/IV).
Background summary
Rationale: Illness perceptions (IPs), medication beliefs, Fear of cancer recurrence (FCR) and quality of life (QoL) may influence adherence to endocrine therapy (ET) in patients with breast cancer.
Objective: To analyze the predictive value of IPs, medication beliefs and QoL on adherence to adjuvant ET and to create a prediction model with adherence as outcome.
Study design: Descriptive study.
Study population: Women with stage I-III breast cancer treated for their disease at the Leiden University Medical Center, the Haaglanden Medical Center and the Saitama Cancer Center in Japan.
Main study parameters/endpoints: Adherence to ET in the first year in patients with early breast cancer and its association with illness perceptions, medication beliefs and QoL.
Study objective
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.
To study adherence to endocrine therapy at 3 and 6 months.
To compare cross-cultural differences of illness perceptions, medication beliefs, quality of life and adherence to ET in women with breast cancer.
To determine the ability to retain/resume work.
To observe and evaluate occurrence of side effects (grade III/IV).
Study design
Patients will be asked to fill out multiple questionnaires at the following time points; at baseline and after 3, 6 and 12 months of starting with endocrine therapy.
Intervention
none
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8541 |
| Other | METC-LDD : N19.122 |