Clinical trial · Observational
Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer
Effectiveness of persoNalized Care After Treatment for Nonmetastasized Breast Cancer Based On Risk of Recurrence, Personal Needs and Risk on (Late) Health Effects: the NABOR Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly 'one-size-fits-all', but can be personalized based on patients' risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up. The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: 'what is 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)'. Also 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 will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated. Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR). The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care. In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| personalized surveillance plans (PSP) and personalized aftercare plans (PAP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Care as usual
- description
- Participants who are included during care as usual, before the hospital's transition to personalized follow-up. Care as usual is organized as 'one-size fits all' and does not take individual differences in prognoses and needs into account. For the majority of hospitals follow-up includes annual mammography and physical examination combined with discussing of the results of the mammogram and sometimes also the patient's needs.
- label
- Personalized care
- description
- Participants who are included after the hospital's transition to personalized follow-up. After this transition, personalized follow-up becomes the standard form of care for all patients, regardless of their participation in this study. Participants of this group receive personalized follow-up, which is based on individual prognoses and needs. Personalized follow-up will be provided by the use of personalized surveillance (PSP) and personalized aftercare plans (PAP).
- interventionNames
- Other: personalized surveillance plans (PSP) and personalized aftercare plans (PAP)
Primary outcomes (2)
- measure
- Change in cancer worry
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * female, * aged 40 years or older (because of higher risk on recurrence), * facing the decision for the organization of post-treatment surveillance and aftercare, * being curatively treated including breast surgery, for invasive non-metastasized breast cancer * able to understand the Dutch language in speech and writing. Exclusion Criteria: * bilateral breast cancers, * BRCA1/2 or CHEK2 carriers, * having an indication for MRI * participation in another study that requires fixed scheduled follow-up consultations and/or imaging.
References
Publications (2)
- BACKGROUNDLuigjes-Huizer YL, van der Lee ML, Richel C, Masselink RA, de Wit NJ, Helsper CW. Patient-reported needs for coping with worry or fear about cancer recurrence and the extent to which they are being met: a survey study. J Cancer Surviv. 2024 Jun;18(3):791-799. doi: 10.1007/s11764-022-01326-5. Epub 2022 Dec 30. PMID 36585574
- DERIVEDKlaassen-Dekker A, Drossaert CHC, Van Maaren MC, Van Leeuwen-Stok AE, Retel VP, Korevaar JC, Siesling S; NABOR project group. Personalized surveillance and aftercare for non-metastasized breast cancer: the NABOR study protocol of a multiple interrupted time series design. BMC Cancer. 2023 Nov 14;23(1):1112. doi: 10.1186/s12885-023-11504-y. PMID 37964214