What matters in clinical trial decision-making: a systematic review of interviews exploring cancer patients' experiences

Abstract

Background: Being diagnosed with cancer is an existential challenge and involves difficult treatment decisions, including treatment in clinical trials. Therapy for advanced cancer is potentially life-prolonging and only rarely cures advanced cancer, which often renders these patients in a special situation where dealing with end of life, hope and meaning, become an important part of life. Many existing reviews include both patients with advanced cancer and patients undergoing adjuvant cancer treatment, and there is a lack of reviews with consistent study designs and methods.

Aim: To systematically review and thematically synthesise the experiences of patients and relatives when they have to decide whether or not to participate in a clinical oncology trial and to provide knowledge about the decision-making process.

Method: A qualitative systematic literature review was conducted based on methods for thematic synthesis by Thomas and Hardens.

Results: Eleven full-text articles were included in this study. Six descriptive themes appeared and were grouped under two analytical themes: Individualised decisions and Hope and existential matters, which, through discussion, developed into the synthesis of What matters in treatment-related decisions close to the end of life? This review has shown that existential matters are important in the decision-making and that addressing these might be of great importance in medical decision-making, whether it concerns the existential matters of the patients, of their relatives or of the health care professionals.

Conclusion: This review points to existential issues as important contributors in making decisions about treatment. It can be beneficial if health care professionals address the role of existential matters in patients' decision-making in terms of clinical trial participation and involve the relatives more directly to increase individualised decisions. Future research should include the health care professionals' experiences when going in depth with decision-making, with a focus on the existential matters and uncertainties of the health care professionals.

Keywords: advanced cancer; communication; decision-making; existential issues; literature review; patient communication; qualitative studies; treatment; whole person care.