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"I have a lot of pills in my bag, you know": Institutional Norms in the Provision of Hope in Phase 1 Clinical Cancer Trials
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
2017 (English)In: Journal of Oncology Pharmacy Practice, ISSN 1078-1552, E-ISSN 1477-092X, Vol. 13, no 10, 679-682 p.Article in journal, Editorial material (Refereed) Published
Abstract [en]

Hope of a miracle cure is often an important motive for participating in phase 1 clinical cancer trials. Communication of hope may stimulate patients to participate and may enhance their quality of life; however, it may also deprive them of an opportunity to spend the remainder of their lives as they wish. Much depends on the kind of hope involved. This article outlines three forms of hope entertained by trial participants that, in various ways, are triggered, enhanced or modified by institutional norms within health care. This has normative as well as clinical implications; the information threshold for informed consent to enter phase 1 trials should be higher than that for consenting to medical treatment or entering randomised, controlled, phase 3 trials, clarifying the demarcation between clinical treatment and research. A simultaneous care model that integrates both trial participation and palliative care could and should also be offered; this is in line with the recommendations of the WHO, which state that palliative care should be applicable early in the course of illness. 

Place, publisher, year, edition, pages
2017. Vol. 13, no 10, 679-682 p.
Keyword [en]
Clinical trials phase 1, cancer, palliative, hope
National Category
Medical Ethics Cancer and Oncology
Research subject
Bioethics
Identifiers
URN: urn:nbn:se:uu:diva-252879DOI: 10.1200/JOP.2017.021832ISI: 000414677100014PubMedID: 28837376OAI: oai:DiVA.org:uu-252879DiVA: diva2:811909
Funder
Swedish Cancer Society
Available from: 2015-05-13 Created: 2015-05-13 Last updated: 2017-11-23Bibliographically approved
In thesis
1. Patients in Clinical Cancer Trials: Understanding, Motivation and Hope
Open this publication in new window or tab >>Patients in Clinical Cancer Trials: Understanding, Motivation and Hope
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The overall aim of this thesis was to study participants' understanding of clinical cancer trials, and their motivation for participation. Of particular interest was the question of whether the patients hoped for a cure resulting from the trial. The thesis was based on four studies and used three methods: interviews, a questionnaire, and empirical bioethics. The results of Study I indicated that the participants in phase 1 trials understood most of the information provided, but were unaware of both the very small potential for treatment benefit, and the risk of harm. Patients in phase 3 trials had a good understanding of the trial, except regarding side effects and their right to withdraw. Some found it hard to ask questions and felt they needed more information (Study III). The participants in phase 1 trials were strongly motivated by the generally unrealistic hope for therapeutic benefit (Study I). When the chances of a cure are minuscule, as for participants with end-stage cancer in phase 1 trials, hope can play an important, positive role and offer meaning to one’s remaining life. However, hope for an unrealistic outcome could also deprive patients of an opportunity to spend their remaining lives, as they would otherwise choose (Study II). The participants in phase 3 trials indicated that their motivation for participation was multifaceted; the most common motivations included hope of therapeutic benefit, altruism, access to extra clinical examinations or better care, and a wish to repay society for the help they had received (Study III). After stratifying and analysing the motivation data by gender, age, education and previous experience of trial participation, males and those aged ≥65 years were significantly more motivated to participate out of a desire to reciprocate the help they had received, either because of a sense of duty or because their families or friends considered that they should attend (Study IV). In conclusion, the informed consent process seems to work relatively well, with good results within most subgroups. However, patients with end-stage cancer who are participating in phase 1 trials are a vulnerable group as they have very little potential for treatment benefit coupled with a tangible risk of harm.

 

Place, publisher, year, edition, pages
Uppala: Uppsala universitet, 2015. 79 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1112
Keyword
cancer, adults, clinical trials, phase 1 trials, phase 3 trials, patient information, patient education, informed consent, hope
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-252542 (URN)978-91-554-9268-7 (ISBN)
Public defence
2015-08-28, BMC, A1:107a, BMC, Husargatan 3, Uppsala, 09:15 (Swedish)
Opponent
Supervisors
Funder
Swedish Cancer Society
Available from: 2015-06-05 Created: 2015-05-08 Last updated: 2015-07-07Bibliographically approved

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Godskesen, ToveKihlbom, Ulrik

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