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Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation

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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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Acknowledgments

The investigators wish to thank the trial participants for taking the time to participate in this study and for sharing their experiences and thoughts. We also thank the research nurses at the Research and Development Unit at Uppsala University Hospital and Clinical Trial Unit at Karolinska University Hospital, for their assistance with patient recruitment. This work was supported by grants from the Swedish Cancer Society.

Conflict of interest

The authors have declared no conflicts of interest.

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Authors and Affiliations

  1. Centre for Research Ethics & Bioethics, Uppsala University, Uppsala, Sweden

    Tove Godskesen, Mats Hansson & Ulrik Kihlbom

  2. Department of Radiology, Oncology, and Radiation Sciences, Uppsala University, Uppsala, Sweden

    Peter Nygren

  3. Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden

    Karin Nordin

  4. Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway

    Karin Nordin

Authors
  1. Tove Godskesen
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  2. Peter Nygren
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  3. Karin Nordin
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  4. Mats Hansson
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  5. Ulrik Kihlbom
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Corresponding author

Correspondence to Tove Godskesen.

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Godskesen, T., Nygren, P., Nordin, K. et al. Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation. Support Care Cancer 21, 3137–3142 (2013). https://doi.org/10.1007/s00520-013-1891-7

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  • DOI: https://doi.org/10.1007/s00520-013-1891-7

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