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Cancer patient decision making related to clinical trial participation: an integrative review with implications for patients’ relational autonomy

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Abstract

Purpose

Oncology clinical trials are necessary for the improvement of patient care as they have the ability to confirm the efficacy and safety of novel cancer treatments and in so doing, contribute to a solid evidence base on which practitioners and patients can make informed treatment decisions. However, only 3–5 % of adult cancer patients enroll in clinical trials. Lack of participation compromises the success of clinical trials and squanders an opportunity for improving patient outcomes. This literature review summarizes the factors and contexts that influence cancer patient decision making related to clinical trial participation.

Methods

An integrative review was undertaken within PubMed, CINAHL, and EMBASE databases for articles written between 1995 and 2012 and archived under relevant keywords. Articles selected were data-based, written in English, and limited to adult cancer patients.

Results

In the 51 articles reviewed, three main types of factors were identified that influence cancer patients’ decision making about participation in clinical trials: personal, social, and system factors. Subthemes included patients’ trust in their physician and the research process, undue influence within the patient-physician relationship, and systemic social inequalities. How these factors interact and influence patients’ decision-making process and relational autonomy, however, is insufficiently understood.

Conclusions

Future research is needed to further elucidate the sociopolitical barriers and facilitators of clinical trial participation and to enhance ethical practice within clinical trial enrolment. This research will inform targeted education and support interventions to foster patients’ relational autonomy in the decision-making process and potentially improve clinical trial participation rates.

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Notes

  1. It is not clear in many of these studies whether physicians informing patients about CTs were treating physicians or physician-investigators. This difference may have important implications for patients’ relational autonomy. For example, the dual role of physician-investigators may impact the trust patients have in these physicians and the way in which information was provided, since physician-investigators could have secondary interests that conflict with the patient’s best interest.

  2. Clinical equipoise means there is genuine uncertainty in the expert medical community about whether a treatment will be beneficial [82].

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Acknowledgments

Funding for this project was received from the Canadian Institutes of Health Research (CIHR)–Institute Ethics office. JAHB was supported by a CIHR Doctoral Research Award and a CIHR Psychosocial Oncology Research Training (PORT) fellowship. LGB was supported by a  CIHR New Investigator Award (2008-2013).

Conflict of interest

The authors (JAHB and LGB) declare that they have no competing interests.

Authors’ contributions

JAHB carried out this research as part of her doctoral dissertation. She collected and analyzed the data and drafted the manuscript. LGB participated in the presentation of ideas in the manuscript and reviewed and provided significant feedback on the manuscript. All authors read and approved the final manuscript.

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Authors and Affiliations

  1. Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada

    Jennifer A. H. Bell & Lynda G. Balneaves

  2. Joint Centre for Bioethics, University of Toronto, Toronto, Canada

    Jennifer A. H. Bell

  3. Department of Psychiatry, University of Toronto, Toronto, Canada

    Jennifer A. H. Bell & Lynda G. Balneaves

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  1. Jennifer A. H. Bell
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Correspondence to Jennifer A. H. Bell.

Appendices

Appendices

Table 4 Quantitative research studies reviewed
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Table 5 Qualitative research studies reviewed
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Bell, J.A.H., Balneaves, L.G. Cancer patient decision making related to clinical trial participation: an integrative review with implications for patients’ relational autonomy. Support Care Cancer 23, 1169–1196 (2015). https://doi.org/10.1007/s00520-014-2581-9

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