Recruitment challenges to the I CARE study: a randomised trial on general practitioner-led colon cancer survivorship care

Abstract

ObjectivesThe I CARE study (Improving Care After colon canceR treatment in the Netherlands) aims to compare surgeon-led to general practitioner (GP)-led colon cancer survivorship care. Recruitment to the trial took longer than expected. In this descriptive study, recruitment is critically reviewed.SettingPatients were recruited from eight Dutch medical centres.ParticipantsPatients treated with curative intent for stages I–III colon cancer. Target patient sample size was calculated at 300.InterventionsPatients were randomised to surgeon-led (usual) versus GP-led care, with or without access to an eHealth application (Oncokompas).Outcome measuresBaseline characteristics of (non-)participants, reasons for non-participation and strategies to improve recruitment were reviewed.ResultsOut of 1238 eligible patients, 353 patients were included. Of these, 50 patients dropped out shortly after randomisation and before start of the intervention, resulting in a participation rate of 25%. Participants were on average slightly younger (68.1 years vs 69.3 years) and more often male (67% vs 50%) in comparison to non-participants. A total of 806 patients declined participation for reasons most often relating to research (57%), including the wish to remain in specialist care (31%) and too much effort to participate (12%). Some patients mentioned health (9%) and confrontation with the disease (5%) as a reason. In 43 cases, GPs declined participation, often related to the study objective, need for financial compensation and time restraints. The generally low participation rate led to concerns about reaching the target sample size. Methods to overcome recruitment challenges included changes to the original recruitment procedure and the addition of new study centres.ConclusionsChallenges were faced in the recruitment to a randomised trial on GP-led colon cancer survivorship care. Research on the transition of care requires sufficient time, funding and support base among patients and healthcare professionals. These findings will help inform researchers and policy-makers on the development of future practices.Trial registration numberNTR4860.

Delivering colon cancer survivorship care in primary care; a qualitative study on the experiences of general practitioners

“…Challenges were faced in the recruitment of the I CARE study, resulting in an extended recruitment period [ 29 ]. Inherent to the I CARE study, selection bias of both patients and GPs could not be excluded.…”

Cost-effectiveness of general practitioner- versus surgeon-led colon cancer survivorship care: an economic evaluation alongside a randomised controlled trial

“…The I CARE study is an ongoing 2 × 2 factorial randomisedcontrolled trial, comparing colon cancer survivorship care by a GP to care by a surgeon, with or without access to Oncokompas, a supporting eHealth application [13]. By the end of 2023, all patients will have finished their 5-year follow-up period [16]. The I CARE study is conducted in eight hospitals in the Netherlands.…”

“…However, cost savings were mostly due to lost productivity costs, which was somewhat unexpected. Shortly after randomisation, 50 patients dropped-out, of which most patients were randomised to their GP [16]. Potential selective dropout may explain why lost productivity was the main contributor to the difference in total societal costs.…”

Patient experiences of GP-led colon cancer survivorship care: a Dutch mixed-methods evaluation

“…Inherent to the design of the I CARE study, a possible risk of selection bias exists (15) . It is plausible that patients who are generally positive about their GP and the intervention are overrepresented in the study population.…”

“…The primary outcome was QoL. A full description of the study procedures and recruitment period were previously published (11,15) . Box 1 provides the definition of colon cancer survivorship care, and how it was operationalized for this study.…”