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ADHERE ADherence to ADjuvant HormonE theRapiEs The association between illness perceptions and adherence to endocrine therapies in patients with breast cancer

ADHERE ADherence to ADjuvant HormonE theRapiEs The association between illness perceptions and adherence to endocrine therapies in patients with breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON19944
Enrollment
200
Registered
2020-04-15
Start date
2020-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study will include women with stage I-III breast cancer who are scheduled to receive adjuvant ET without adjuvant chemotherapy

Interventions

none

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Contacts

Public ContactJony Bruin

LUMC

j.bruin@lumc.nl071-5263121

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)