Effectiveness of persoNalized care After treatment for non-metastasized Breast cancer based On risk of Recurrence, personal needs and risk on (late) health effects: the NABOR study.
Indication
Data registration
Subindication
Any HER2, any HR
Description
Personalized care and personalized surveillance
Target sample size
1040
Actual accrual
535
Date: 01/12/2024
Estimated study completion date
02/11/2025
Number of active sites
10
Contact
Sponsor
IKNL
Principal Investigator(s)
Prof. dr. S. Siesling (IKNL, UT), dr. J.C. Korevaar (NIVEL)
Prospective, multicenter, multiple interrupted time series (MITs) design
Participating sites
Ziekenhuisgroep Twente
Alrijne Ziekenhuis
Gelre Ziekenhuis
Jeroen Bosch Ziekenhuis
NoordWest Ziekenhuis Groep (locatie Alkmaar)
Albert Schweitzer Ziekenhuis
Rijnstate Ziekenhuis
Bernhoven
Isala (locatie Zwolle)
Haaglanden Medisch Centrum
Objectives
Primary objective:
To assess the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS).
Secondary objectives:
To assess the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients’ need for support, shared
decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences.
To assess the uptake and appreciation of the personalized plans and related factors (e.g. patient, caregiver, hospital and societal/financial).
Endpoints
Effectiveness of personalized follow-up compared to standard follow-up care measured in terms of cancer worries and self-rated overall quality of life (EQ-VAS).
Other study parameters are health care costs and resource use, health related quality of life (EQ-5D), and the extent to which applying PSP and PAP improves accurate risk perception, shared decision-making, patient satisfaction, societal participation, and cost-effectiveness without increasing the severity of the detected recurrences. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated.
Eligibility Criteria
In order to be eligible to participate in this study, a patient must meet the following criteria:
Female
Non-metastasized primary invasive breast cancer;
Curatively treated including breast surgery
≥ 40 years of age;
Understand the Dutch language in speech and writing;
Able to provide informed consent.
Both patients who receive neoadjuvant and adjuvant therapy are also eligible to participate.
A potential subject who meets any of the following criteria will be excluded from participation
in this study:
Bilateral breast cancer
BRCA1/2 or CHEK2 carriers
Indication for MRI
Male breast cancer patients
Patients who participate in another study that requires fixed scheduled follow-up
consultations and/or imaging