Deciding to Enrol in a Cancer Trial: A Systematic Review of Qualitative Studies

Abstract

Background

Clinical trials are essential for the advancement of cancer treatments; however, participation by patients is suboptimal. Currently, there is a lack of synthesized qualitative review evidence on the patient experience of trial entry from which to further develop decision support. The aim of this review is to synthesise literature reporting experiences of participants when deciding to enrol in a cancer clinical trial in order to inform practice.

Methods

A systematic review and meta-synthesis of qualitative studies were conducted to describe the experiences of adult cancer patients who decided to enrol in a clinical trial of an anti-cancer treatment.

Results

Forty studies met eligibility criteria for inclusion. Three themes were identified representing the overarching domains of experience when deciding to enrol in a cancer trial: 1) need for trial information; (2) trepidation towards participation; and (3) justifying the decision. The process of deciding to enrol in a clinical trial is one marked by uncertainty, emotional distress and driven by the search for a cure.

Conclusion

Findings from this review show that decision support modelled by shared decision-making and the quality of a shared decision needs to be accompanied by tailored or personalised psychosocial and supportive care. Although the decision process bears similarities to theoretical processes outlined in decision-making frameworks, there are a lack of supportive interventions for cancer patients that are adapted to the clinical trial context. Theory-based interventions are urgently required to support the specific needs of patients deciding whether to participate in cancer trials.

Keywords:

• advanced cancer
• qualitative
• guideline development
• consolidated framework for implementation research

Acknowledgments

This project is supported by the NHMRC Centre for Research Excellence in Prostate Cancer Survivorship APP1098042.

Disclosure

Dr. Nicholas Ralph reports grants from Australian and New Zealand Urogenital and Prostate Cancer Trials Group, during the conduct of the study; fees from 3M Healthcare, outside the submitted work. The authors have declared no other potential conflicts of interest for this work.