Erasmus MC, Dept. of Radiotherapy
Dr. Janine Simons (resident in radiation oncology, EMC)
Prof. dr. Liesbeth Boersma (radiation oncologist, Maastro)
Prof. dr. Marc Mureau (plastic surgeon, EMC)
Clinical study manager: dr. Elise van Leeuwen (BOOG SC)
Project assistant: Suzanne Jager, MSc (BOOG SC)
E: info@boogstudycenter.nl
Coordinating investigator: dr. Janine Simons (EMC)
E: j.simons@erasmusmc.nl
Study coordinator: drs. Simone Schnitzler (EMC)
E: s.schnitzler@erasmusmc.nl
Not applicable
ZonMw Open Ronde Doelmatigheid 2025
The CONRAD study concerns a nationwide retro- and prospective observational cohort study. Data on patient, tumor and treatment characteristics will be collected as well as on complications, costs and recurrences. Data will be retrieved from patients’ medical records and this will be complemented with data from the Netherlands Cancer Registry (NCR) and from Dutch Hospital Data (DHD). Additionally, PROs will be collected at baseline and at 1, 3 and 5 years after mastectomy (or after delayed breast reconstruction, if applicable).
Het voorstel voor de CONRAD-studie is tot stand gekomen dankzij een samenwerking van de hoofdonderzoekers met radiotherapeuten (Desiree van den Bongard, Amsterdam UMC; Sophie Bosma, LUMC; Anne Crijns, UMCG; Femke Froklage, EMC; John Maduro, UMCG; Astrid Scholten, NKI-AvL; Karolien Verhoeven, Maastro), plastisch chirurgen (Marije Hoornweg, NKI-AvL; René van der Hulst, MUMC+; Wies Maarse, UMCU; Andrzej Piatkowski de Grzymala, MUMC+; Hinne Rakhorst, ZGT & MST; Danny Young-Afat, Amsterdam UMC), oncologisch chirurgen (Mirelle Bröker, SFG; Frederieke van Duijnhoven, NKI-AvL; Linetta Koppert, EMC), HTA-expert Hedwig Blommestein (EUR), implementatie-expert Maria Jacobs (Tilburg University, Maastro), BVN, BOOG en IKNL.
Primary research question
What are the outcomes of (refraining from) different breast reconstruction options after mastectomy in terms of potential health gains (PROs), complications, oncological safety) and cost-effectiveness in breast cancer patients with an indication for radiotherapy?
Primary objective
Secondary objectives
Main endpoints
The main study endpoints include the different PROs (by means of BREAST-Q v2 and EQ-5D-5L). The PROs will be collected at baseline and at 1 year after mastectomy.
Secondary endpoints
The secondary endpoints include the different PROs (by means of BREAST-Q v2 and EQ-5D-5L at 3, and 5 years after mastectomy. Secondary endpoints furthermore include complication rates and the economic evaluation. Data on type of complications and complication rates (categorized as early (<90 days after surgery) or late (>90 days after surgery will be collected. The main outcomes of the economic evaluation will be the incremental cost-effectiveness per life-year gained and per quality-adjusted life-year gained. For the economic evaluation, the iMCQ and iPCQ questionnaires will be administered three times, i.e. at baseline, at 3 months and at 1 year after surgery. The other secondary endpoints include time to adjuvant treatment (radiotherapy ± systemic therapy) and breast cancer recurrence risk and vital status up until 5 years.
Inclusion criteria
Exclusion criteria
