Why do breast cancer patients decline entry into randomised trials and how do they feel about their decision later: a prospective, longitudinal, in-depth interview study.

This paper presents an exploration of the reasons why breast cancer patients decline entry into randomised clinical trials of adjuvant cancer therapy. The study employed a qualitative, longitudinal design based on in-depth interview post diagnosis, with follow-up interviews at 6 and 12 months later. Twenty-two consecutive patients, newly diagnosed with breast cancer, who had declined entry into a clinical trial were prospectively recruited from five outpatient breast cancer clinics in the North Trent Cancer Network. Analysis of patients' narratives indicated that fear of the illness and limited understanding of medical research in general, compounded by unhelpful explanations of the trial purpose and process by health professionals, resulted in patients opting for the 'tried and tested' treatment. Some patients had persisting guilt about their decision not to take part. Many of the reasons why breast cancer patients decline entry to clinical trials could be addressed, as they tend to be a product of situational and process factors, rather than being rooted in deep-seated antipathy towards research.