PRIME I was sponsored by the NHS Research and Development Health Technology Assessment Programme, following a call for proposals focusing on quality of life and cancer treatment in older patients.
This phase of the trial involved a research nurse visiting consenting patients in their own homes (unless the patient expressed a preference otherwise) and completing a series of validated questionnaires with the patient four times over a period of 15 months. These were completed:
In addition to the patients whose treatment was randomly allocated, PRIME ran a parallel, non-randomised arm, where patients who declined randomisation were offered the chance to choose their own treatment and still be followed up within the trial. In both cases, patients were monitored in exactly the same way.
Fifty one centres in both Scotland and England were involved with the trial, which ran from July 1999 to August 2004 and recruited 255 patients into the randomised arm and another 100 into the non-randomised arm. Early results are expected to be released in summer 2005, so keep checking the News page.
A copy of the trial protocol can be found here.