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Phase I participants’ views of quality of life and trial participation burdens

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Abstract

Purpose

Participants’ perception of quality of life (QOL) and respondent burden have significant implications for investigators’ ethical responsibilities to their subjects in phase I cancer trials. To address these responsibilities, analysis was conducted on participants’ views of their experiences of a phase I trial, including the associated burdens and what constitutes QOL.

Patients and methods

One hundred potential participants of the endostatin trial were surveyed. Sixteen of the 18 trial participants were interviewed extensively about their experiences on the trial.

Results

Participants described ‘normality’ as a baseline ability to function, be productive, and be free from symptoms of disease and side effects of treatment. Reflecting the relative nontoxicity of the study drug, participants contrasted their current QOL with their negative experience of previous cancer treatments and viewed their QOL as fairly good. However, participants emphasized that indirect and procedural burdens of trial participation had a significant impact on their current QOL.

Conclusions

Candid descriptions of a trial’s practical demands, in addition to potential physical complications in a trial, could improve the quality of informed consent.

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Authors and Affiliations

  1. Health Science Center at Houston, School of Nursing, The University of Texas, 6901 Bertner Ave., Rm 797, Houston, TX, 77030, USA

    Marlene Zichi Cohen

  2. M.D. Anderson Cancer Center Houston, The University of Texas, Houston, TX, USA

    Marlene Zichi Cohen, Rebecca D. Pentz, Anne L. Flamm, David Gold, Roy S. Herbst & James L. Abbruzzese

  3. Winship Cancer Institute, Emory University, Atlanta, GA, USA

    Rebecca D. Pentz

  4. Health Science Center at Houston, School of Public Health, The University of Texas, 6901 Bertner Ave., Rm 797, Houston, TX, 77030, USA

    Jacquelyn Slomka

Authors
  1. Marlene Zichi Cohen
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  2. Jacquelyn Slomka
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  3. Rebecca D. Pentz
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  4. Anne L. Flamm
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  5. David Gold
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  6. Roy S. Herbst
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  7. James L. Abbruzzese
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Corresponding author

Correspondence to Marlene Zichi Cohen.

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Cohen, M.Z., Slomka, J., Pentz, R.D. et al. Phase I participants’ views of quality of life and trial participation burdens. Support Care Cancer 15, 885–890 (2007). https://doi.org/10.1007/s00520-007-0216-0

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  • DOI: https://doi.org/10.1007/s00520-007-0216-0

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