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NABOR

  • Open

BOOG 2022-04

General Information

BOOG number

BOOG 2022-04

Nickname

NABOR

Status

  • Open
Date: 01/03/2023

Participating parties / group

IKNL-UT-NIVEL

Full title

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

424
Date: 01/04/2024

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)

Study manager

Projectmedewerker BOOG: Suzanne Jager (info@boogstudycenter.nl)

Study coordinator

Anneleen Klaassen-Dekker (NABOR@iknl.nl)

Central datamanagement and randomization

PROFIEL

Local datamanagement

NKR-IKNL

Funding

ZEGG

Other

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Uitlegvideo nacontrole keuzehulp – voor zorgverleners

 

 

 

 

 

Uitlegvideo nacontrole keuzehulp – voor patiënten

 

 

 

 

 

Uitlegvideo nazorg keuzehulp – voor patiënten

 

 

 

 

 

ZonMw

https://www.zonmw.nl/nl/onderzoek-resultaten/doelmatigheidsonderzoek/programmas/project-detail/evaluatieonderzoek-zegg/effectiveness-of-personalized-care-after-treatment-for-non-metastasized-breast-cancer-based-on-risk/

Design

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

Regulatory Information

CCMO approval

Not applicable

EC approval

Not applicable

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