Acronym
DISTANCE-trial
Name of the study
Towards patient-led follow-up after curative treatment of stage II and III colorectal cancer
Researchers and contact information
Project leaders:
Prof. dr. J.H.W. (Hans) de Wilt | hans.dewilt@radboudumc.nl
Dr. V.M.H. (Veerle) Coupé | v.coupe@amsterdamumc.nl
Project team member:
Dr. G.R. (Geraldine) Vink | g.vink@iknl.nl
Coordinating investigator:
H. (Hidde) Swartjes | hidde.swartjes@radboudumc.nl
Summary study
Colorectal cancer (CRC) is a common cancer in the Netherlands. After surgical treatment, approximately 20% of stage II/III CRC patients develop a recurrent tumour or metastases. Patients are currently follow for five years after curative resection. However, intensified follow-up after curative resection has shown no effect on survival. Therefore, patients organisations and policy makers call for a more patient-centred, tailored follow-up.
Patient-led, home-based follow-up shows great potential as an alternative for the regular-in hospital follow-up. Implementation of patient-led, home-based follow-up at the Radboud University Medical Center in Nijmegen, the Netherlands led to a 70% decrease in patients having contact with the hospital, and a decrease of more than 60% in cost of CRC follow-up.
The main aim of the DISTANCE-trial is to successfully implement patient-led, home-based follow-up in five hospitals in the Netherlands. Hereto, a stepped-wedge clustered randomized trial (SW-CRT) was designed. During the trial, two centres will implement patient-led, home-based follow-up after six months, the other three centres will implement patient-led, home-based follow-up after 12 months of participation. After the study, all centres will likely continue their patient-led, home-based follow-up programs.
Patients with stage II/III CRC, who are 18 years or older and have been free of disease for 12 months after curative resection are eligible for inclusion. The endpoints of the study will be compared between the regular, in-hospital follow-up and the patient-led, home-based follow-up. The primary
endpoint is the proportion of patients who had contact with the hospital regarding CRC follow-up between 12 and 24 months after curative resection. Secondary endpoints are quality of life, fear of cancer recurrence, patients satisfaction, cost-effectiveness and survival.
Intervention
Control group: in-hospital, standard of care CRC follow-up;
Intervention group: patient-led, home-based CRC follow-up.
Participating centres
Bernhoven Ziekenhuis, Uden (Approved by RvB)
Catharina Ziekenhuis, Eindhoven (Approved by RvB)
Gerle Ziekenhuizen, Apeldoorn
Jeroen Bosch Ziekenhuis, ’s-Hertogenbosch
Rijnstate Ziekenhuis, Arnhem