| 1. |
- Godskesen, Tove, et al.
(författare)
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Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials
- 2015
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Ingår i: European Journal of Cancer Care. - : Wiley-Blackwell. - 0961-5423 .- 1365-2354. ; 24:1, s. 133-41
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 2. |
- Godskesen, Tove, et al.
(författare)
-
Phase 1 clinical trials in end-stage cancer : patient understanding of trial premises and motives for participation
- 2013
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Ingår i: Supportive Care in Cancer. - : Springer Science and Business Media LLC. - 0941-4355 .- 1433-7339. ; 21:11, s. 3137-3142
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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