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

Abstract

Objectives: The 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.

Setting: Patients were recruited from eight Dutch medical centres.

Participants: Patients treated with curative intent for stages I-III colon cancer. Target patient sample size was calculated at 300.

Interventions: Patients were randomised to surgeon-led (usual) versus GP-led care, with or without access to an eHealth application (Oncokompas).

Outcome measures: Baseline characteristics of (non-)participants, reasons for non-participation and strategies to improve recruitment were reviewed.

Results: Out 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.

Conclusions: Challenges 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 number: NTR4860.

Keywords: gastrointestinal tumours; primary care; qualitative research.

Figure 1

Trial flow diagram. *Participants who withdrew study consent shortly after randomisation. GPs, general practitioners.

Figure 2

Chronic comorbid conditions. *Other chronic comorbid conditions were reported by less than 5% of the participants and included ear, nose, throat diseases, skin disorders, eye disorders, infectious disorders and blood disorders.