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Patients in Clinical Cancer Trials: Understanding, Motivation and Hope
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
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 [en]
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: urn:nbn:se:uu:diva-252542ISBN: 978-91-554-9268-7 (print)OAI: oai:DiVA.org:uu-252542DiVA: diva2:810770
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
List of papers
1. Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation
Open this publication in new window or tab >>Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation
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2013 (English)In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 21, no 11, 3137-3142 p.Article in journal (Refereed) Published
Abstract [en]

In cancer, phase 1 clinical trials on new drugs mostly involve patients with advanced disease that is unresponsive to standard therapy. The purpose of this study was to explore the difficult ethical problems related to patient information and motives for participation in such trials. A descriptive and explorative qualitative design was used. Fourteen cancer patients from three different phase 1 trials in end-stage cancer were interviewed. The interviews were analysed using qualitative content analysis. The patients expressed unrealistic expectations of therapeutic benefit and inadequate understanding of the trials' purpose, so-called therapeutic misconception. However, they reported a positive attitude towards participation. Thus, the patients valued the close and unique medical and psychological attention they received by participating. Participation also made them feel unique and notable. Patients with end-stage cancer participating in phase 1 clinical trials are unaware of the very small potential for treatment benefit and the risk of harm. Trial participation may offer hope and social-emotional support and a strategy for coping with the emotional stress associated with advanced cancer and may, consequently, improve emotional well-being.

Keyword
Cancer, Clinical trials, Ethics, Sweden
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-210174 (URN)10.1007/s00520-013-1891-7 (DOI)000325390600024 ()
Available from: 2013-11-04 Created: 2013-11-04 Last updated: 2015-06-08Bibliographically approved
2. "I have a lot of pills in my bag, you know": Institutional Norms in the Provision of Hope in Phase 1 Clinical Cancer Trials
Open this publication in new window or tab >>"I have a lot of pills in my bag, you know": Institutional Norms in the Provision of Hope in Phase 1 Clinical Cancer Trials
(English)Manuscript (preprint) (Other academic)
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. 

Keyword
Clinical trials phase 1, cancer, palliative, hope
National Category
Medical and Health Sciences
Research subject
Bioethics
Identifiers
urn:nbn:se:uu:diva-252879 (URN)
Available from: 2015-05-13 Created: 2015-05-13 Last updated: 2015-06-08
3. Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials
Open this publication in new window or tab >>Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials
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2015 (English)In: European Journal of Cancer Care, ISSN 0961-5423, E-ISSN 1365-2354, Vol. 24, no 1, 133-141 p.Article in journal (Refereed) Published
Abstract [en]

It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate 92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show adequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction.

National Category
Other Medical Sciences
Identifiers
urn:nbn:se:uu:diva-224616 (URN)10.1111/ecc.12184 (DOI)000346768500014 ()24467443 (PubMedID)
Available from: 2014-05-15 Created: 2014-05-14 Last updated: 2015-06-08Bibliographically approved
4. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials
Open this publication in new window or tab >>Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials
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2016 (English)In: European Journal of Cancer Care, ISSN 0961-5423, E-ISSN 1365-2354, Vol. 25, no 3, 516-523 p.Article in journal (Refereed) Published
Abstract [en]

While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups.

Keyword
adults, cancer, clinical trials, patient education, patient information, phase 3 trials
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-252539 (URN)10.1111/ecc.12319 (DOI)000375066900018 ()25904313 (PubMedID)
Funder
Swedish Cancer Society
Available from: 2015-05-08 Created: 2015-05-08 Last updated: 2016-06-22Bibliographically approved

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