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Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation
Uppsala universitet.ORCID-id: 0000-0001-6011-6740
Uppsala universitet.
Uppsala universitet, Universitetet i Bergen.
Uppsala universitet.
Vise andre og tillknytning
2013 (engelsk)Inngår i: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 21, nr 11, s. 3137-3142Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

BACKGROUND: 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.

METHOD: 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.

RESULTS: 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.

CONCLUSIONS: 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.

sted, utgiver, år, opplag, sider
2013. Vol. 21, nr 11, s. 3137-3142
Emneord [en]
Cancer, Clinical trials, Ethics, Sweden
HSV kategori
Identifikatorer
URN: urn:nbn:se:esh:diva-6971DOI: 10.1007/s00520-013-1891-7PubMedID: 23864288OAI: oai:DiVA.org:esh-6971DiVA, id: diva2:1253662
Tilgjengelig fra: 2018-10-05 Laget: 2018-10-05 Sist oppdatert: 2018-11-08bibliografisk kontrollert
Inngår i avhandling
1. Patients in Clinical Cancer Trials: Understanding, Motivation and Hope
Åpne denne publikasjonen i ny fane eller vindu >>Patients in Clinical Cancer Trials: Understanding, Motivation and Hope
2015 (engelsk)Doktoravhandling, med artikler (Annet vitenskapelig)
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.

sted, utgiver, år, opplag, sider
Uppsala: Uppsala universitet, 2015. s. 79
Serie
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1112
Emneord
Cancer, Adults, Clinical trials, Phase 1 trials, Phase 3 trials, Patient information, Patient education, Informed consent, Hope
HSV kategori
Identifikatorer
urn:nbn:se:esh:diva-7090 (URN)978-91-554-9268-7 (ISBN)
Disputas
2015-08-28, BMC, A1:107a, Husargatan 3, Uppsala, 09:15 (svensk)
Opponent
Veileder
Tilgjengelig fra: 2018-11-08 Laget: 2018-11-08 Sist oppdatert: 2018-11-08bibliografisk kontrollert

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