A Randomised Controlled Trial to Assess the Cost-effectiveness of Intensive Versus no Scheduled Follow-up in Patients Who Have Undergone Resection for Colorectal Cancer With Curative Intent. (FACS - Follow-up After Colorectal Surgery)
- To assess the effect of augmenting symptomatic follow-up in primary care with two
intensive methods of follow-up (monitoring tumor marker in primary care and intensive
imaging in hospital) on survival of patients with stage I, II, or III colorectal cancer
who have undergone curative resection.
- Determine the quality of life of these patients.
- Determine the cost of National Health Service (NHS) services utilized.
- Determine the NHS cost per life-year saved.
OUTLINE: This is a multicenter study. Patients are stratified according to certainty of need
for imaging follow-up, as determined by the local clinician (uncertain vs certain). Patients
are randomized to 1 of 4 follow-up arms.
- Arm I (primary care follow-up): Patients undergo symptomatic follow-up (i.e., are asked
to contact their physician if they have symptoms suggestive of disease recurrence).
Some patients may also undergo a single CT scan 12-18 months post-randomization.
- Arm II (primary care follow-up): Patients undergo tumor marker measurements (CEA) at
baseline, every 3 months for 2 years, and every 6 months for 3 years. Some patients may
also undergo a single CT scan 12-18 months post-randomization.
- Arm III (intensive hospital follow-up): Patients undergo CT scan or MRI at baseline,
every 6 months for 2 years, and then annually for 3 years.
- Arm IV (primary care and intensive hospital follow-up): Patients undergo primary care
and intensive hospital follow-up as in arms II (without the single CT scan) and III.
All patients receive a handbook from their physician detailing possible symptoms suggestive
of disease recurrence.
Quality of life is assessed at baseline and then annually for 5 years.
Overall survival by intention-to-treat analysis
John N. Primrose, MD
University Hospital Southampton NHS Foundation Trust.