TY - JOUR
T1 - Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial)
T2 - a study protocol for a stepped-wedge cluster-randomised trial
AU - Swartjes, Hidde
AU - Qaderi, Seyed M.
AU - Teerenstra, Steven
AU - Custers, Jose A. E.
AU - Elferink, Marloes A. G.
AU - van Wely, Bob J.
AU - Burger, Jacobus W. A.
AU - van Grevenstein, Wilhelmina M. U.
AU - van Duijvendijk, Peter
AU - Verdaasdonk, Emiel G. G.
AU - de Roos, Marnix A. J.
AU - Coupé, Veerle M. H.
AU - Vink, Geraldine R.
AU - Verhoef, Cornelis
AU - de Wilt, Johannes H. W.
N1 - Funding Information: The present study was funded by The Netherlands Organisation for Health Research and Development (ZonMw/Netherlands[10330022010001]). The grant was paid to the institution. The funder had no role in the design of the study, the collection analysis, and interpretation of data and in writing the manuscript. Funding Information: The authors would like to thank the registration team of the Netherlands Comprehensive Cancer Organization (IKNL) for the collection of data for the Netherlands Cancer Registry (NCR). https://onderzoekmetmensen.nl/en/trial/20781. Version 10, December 2022 Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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).
AB - 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).
KW - Aftercare
KW - Colorectal neoplasms
KW - Follow-up studies
KW - Surveillance
KW - Telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85170172880&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12885-023-11297-0
DO - https://doi.org/10.1186/s12885-023-11297-0
M3 - Article
C2 - 37679735
SN - 1471-2407
VL - 23
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 838
ER -