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ENROLLING BY INVITATION
NCT05975437

Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer

Sponsor: Comprehensive Cancer Centre The Netherlands

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1040

Start Date

2023-03-06

Completion Date

2027-03-06

Last Updated

2023-08-03

Healthy Volunteers

No

Interventions

OTHER

personalized surveillance plans (PSP) and personalized aftercare plans (PAP)

The PSP contains decisions on the surveillance trajectory based on individual risks and needs, assessed with the 'Breast Cancer Surveillance Decision Aid' including the INFLUENCE prediction tool. The PAP contains decisions on the aftercare trajectory based on individual needs and preferences and available care resources, which decision-making is supported by a patient decision aid.

Locations (10)

Gelre Ziekenhuizen

Apeldoorn, Gelderland, Netherlands

Rijnstate

Arnhem, Gelderland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Bernhoven Ziekenhuis

Uden, North Brabant, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands

Ziekenhuisgroep Twente

Hengelo, Overijssel, Netherlands

Isala Klinieken

Zwolle, Overijssel, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Alrijne Ziekenhuis

Leiderdorp, South Holland, Netherlands

Haaglanden Medisch Centrum

The Hague, South Holland, Netherlands