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Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.
Uppsala universitet.ORCID iD: 0000-0001-6011-6740
Uppsala universitet.
Uppsala universitet, Universitetet i Bergen.
Uppsala universitet.
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2016 (English)In: European Journal of Cancer Care, ISSN 0961-5423, E-ISSN 1365-2354, Vol. 25, no 3, p. 516-23Article 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.

Place, publisher, year, edition, pages
2016. Vol. 25, no 3, p. 516-23
Keywords [en]
Adults, Cancer, Clinical trials, Patient education, Patient information, Phase 3 trials
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:esh:diva-6969DOI: 10.1111/ecc.12319PubMedID: 25904313OAI: oai:DiVA.org:esh-6969DiVA, id: diva2:1253668
Available from: 2018-10-05 Created: 2018-10-05 Last updated: 2018-11-08Bibliographically 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 thepatients hoped for a cure resulting from the trial. The thesis was based on four studies andused three methods: interviews, a questionnaire, and empirical bioethics. The results of Study Iindicated that the participants in phase 1 trials understood most of the information provided, butwere unaware of both the very small potential for treatment benefit, and the risk of harm. Patientsin phase 3 trials had a good understanding of the trial, except regarding side effects and their rightto withdraw. Some found it hard to ask questions and felt they needed more information (StudyIII). The participants in phase 1 trials were strongly motivated by the generally unrealistic hopefor therapeutic benefit (Study I). When the chances of a cure are minuscule, as for participantswith end-stage cancer in phase 1 trials, hope can play an important, positive role and offermeaning to one’s remaining life. However, hope for an unrealistic outcome could also deprivepatients 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 participationwas 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 helpthey 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 yearswere significantly more motivated to participate out of a desire to reciprocate the help theyhad received, either because of a sense of duty or because their families or friends consideredthat they should attend (Study IV). In conclusion, the informed consent process seems to workrelatively well, with good results within most subgroups. However, patients with end-stagecancer who are participating in phase 1 trials are a vulnerable group as they have very littlepotential for treatment benefit coupled with a tangible risk of harm.

Place, publisher, year, edition, pages
Uppsala: Uppsala universitet, 2015. p. 79
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1112
Keywords
Cancer, Adults, Clinical trials, Phase 1 trials, Phase 3 trials, Patient information, Patient education, Informed consent, Hope
National Category
Nursing
Identifiers
urn:nbn:se:esh:diva-7090 (URN)978-91-554-9268-7 (ISBN)
Public defence
2015-08-28, BMC, A1:107a, Husargatan 3, Uppsala, 09:15 (Swedish)
Opponent
Supervisors
Available from: 2018-11-08 Created: 2018-11-08 Last updated: 2018-11-08Bibliographically approved

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