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BMC Cancer
Published in: BMC Cancer 1/2023

Open Access 01-12-2023 | Study Protocol

Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial): a study protocol for a stepped-wedge cluster-randomised trial

Authors: Hidde Swartjes, Seyed M. Qaderi, Steven Teerenstra, Jose A. E. Custers, Marloes A. G. Elferink, Bob J. van Wely, Jacobus W. A. Burger, Wilhelmina M. U. van Grevenstein, Peter van Duijvendijk, Emiel G. G. Verdaasdonk, Marnix A. J. de Roos, Veerle M. H. Coupé, Geraldine R. Vink, Cornelis Verhoef, Johannes H. W. de Wilt

Published in: BMC Cancer | Issue 1/2023

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Abstract

Background

Colorectal cancer (CRC) is among the most frequently diagnosed cancers. Approximately 20–30% of stage I-III CRC patients develop a recurrent tumour or metastases after curative surgical resection. Post-operative follow-up is indicated for the first five years after curative surgical resection. As intensified follow-up after curative surgical resection has shown no effect on survival, patient organisations and policy makers have advocated for a more patient-centred approach to follow-up. The objective of this study is to successfully implement patient-led, home-based follow-up (PHFU) in six hospitals in The Netherlands, with as ultimate aim to come to a recommendation for a patient-centred follow-up schedule for stage I-III CRC patients treated with surgical resection with curative intent.

Methods

This study is designed as a stepped-wedge cluster-randomised trial (SW-CRT) in six participating centres. During the trial, three centres will implement PHFU after six months; the other three centres will implement PHFU after 12 months of inclusion in the control group. Eligible patients are those with pT2-4N0M0 or pT1-4N1-2M0 CRC, who are 18 years or older and have been free of disease for 12 months after curative surgical resection. The studied intervention is PHFU, starting 12 months after curative resection. The in-hospital, standard-of-care follow-up currently implemented in the participating centres functions as the comparator. The proportion of patients who had contact with the hospital regarding CRC follow-up between 12–24 months after curative surgical resection is the primary endpoint of this study. Quality of life, fear of cancer recurrence, patient satisfaction, cost-effectiveness and survival are the secondary endpoints.

Discussion

The results of this study will provide evidence on whether nationwide implementation of PHFU for CRC in The Netherlands will be successful in reducing contact between patient and health care provider. Comparison of PROMs between in-hospital follow-up and PHFU will be provided. Moreover, the cost-effectiveness of PHFU will be assessed.

Trial registration

Dutch Trail Register (NTR): NL9266 (Registered on January 1st, 2021).
Appendix
Available only for authorised users
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Metadata
Title
Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial): a study protocol for a stepped-wedge cluster-randomised trial
Authors
Hidde Swartjes
Seyed M. Qaderi
Steven Teerenstra
Jose A. E. Custers
Marloes A. G. Elferink
Bob J. van Wely
Jacobus W. A. Burger
Wilhelmina M. U. van Grevenstein
Peter van Duijvendijk
Emiel G. G. Verdaasdonk
Marnix A. J. de Roos
Veerle M. H. Coupé
Geraldine R. Vink
Cornelis Verhoef
Johannes H. W. de Wilt
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2023
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-023-11297-0

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