Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: qualitative study

Abstract

BackgroundThe purpose of this study was to explore women's views of the design of a large pragmatic cost-effectiveness randomised controlled trial of the policy of offering a health professional-delivered intervention to promote early presentation with breast symptoms in older women and thereby improve survival, with a view to informing protocol development. The trial will recruit over 100,000 healthy women aged 67+, and outcome data will be collected on those who develop breast cancer. The scale of the trial and the need for long-term follow-up presented a number of design challenges in relation to obtaining consent, ascertaining and contacting participants who developed breast cancer, and collecting outcome data.MethodsQualitative study involving 69 women participating in 7 focus groups and 17 in-depth interviews. 15 women had a previous diagnosis of breast cancer and 54 did not.ResultsThe women held strong views and had a good understanding of the rationale of the design of clinical trials. The women recognised that in a very large trial with long-term follow-up it was necessary to incorporate design features to make the trial feasible and efficient. Most strikingly, they supported the idea of opt-out consent and identifying women with breast cancer using routine datasets.ConclusionsThis model of user involvement engaged women well with the design challenges of the trial and led to improvements to the protocol. The study strengthens the case for user involvement, in particular through focus groups and in-depth interviews, in the design of trials.

Exploring Attitudes towards a Randomised Controlled Trial of Venous access Devices – a Nested Pre-trial Qualitative Study

“…The search covered two main areas of research: firstly, patient and clinical staff attitudes to RCTs and secondly, patient and clinical staff attitudes to venous access devices. Many qualitative studies have explored the views of cancer patients to the process of RCTs, exploring informed consent (12,13), understanding of equipoise (14), randomisation (15), recruitment (13,14,16) and participation in trial design (17). Despite this, recent research reveals health professionals' discomfort at approaching patients to discuss participation in an RCT at an already stressful period for the patient (17).…”

“…Many qualitative studies have explored the views of cancer patients to the process of RCTs, exploring informed consent (12,13), understanding of equipoise (14), randomisation (15), recruitment (13,14,16) and participation in trial design (17). Despite this, recent research reveals health professionals' discomfort at approaching patients to discuss participation in an RCT at an already stressful period for the patient (17). In addition, whilst several qualitative studies examine patient experiences of a single device (18)(19)(20)(21)(22)(23), few examine patients' attitudes to device choice; those which do, focus on educational and information needs in relation to device selection (24,25).…”

ReseArch with Patient and Public invOlvement: a RealisT evaluation – the RAPPORT study

“…Several researchers have identified that PPI has helped them address ethical dilemmas, 17,71,78,85,91 for example ethically appropriate ways of contacting women with recently diagnosed breast cancer and the use of routine patient data. 92 There is also some suggestion that lay co-researchers have a role to play in helping safeguard potentially vulnerable participants. 82 The impact of PPI has a moral dimension in the reported outcomes for service users and the public involved in the study.…”

Interventions developed with the Intervention Mapping protocol in the field of cancer: A systematic review

“…Forty additional publications were retrieved reporting their needs assessment (n = 18), their step 4 (n = 3), their implementation planning (n = 1), their evaluation (n = 17), and their implementation (n = 1).…”