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Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations

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Abstract

Background. Accepted practices of informed consent often result in suboptimal patient understanding of research studies.Methods. This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial.Results. There were no major differences between groups. Participants rated tailored materials higher as a useful reference.Conclusions. Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research.

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Author notes

  1. Ricardo J. Wray PhD

    Present address: Department of Community Health, School of Public Health, Saint Louis University, 3545 Lafayette Ave., Room 411, 63104, St. Louis, MO

Authors and Affiliations

  1. Dana-Farber Cancer Institute, Boston, MA

    Eric Winer MD, George Demetri MD & Karen M. Emmons PhD

  2. Emory University School of Public Health, USA

    Jo Ellen Stryker PhD

  3. Harvard Medical School, USA

    Eric Winer MD & George Demetri MD

  4. Harvard School of Public Health, USA

    Karen M. Emmons PhD

Authors
  1. Ricardo J. Wray PhD
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  2. Jo Ellen Stryker PhD
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  3. Eric Winer MD
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  4. George Demetri MD
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  5. Karen M. Emmons PhD
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Corresponding author

Correspondence to Ricardo J. Wray PhD.

Additional information

Supported by the Dana-Farber Cancer Institute.

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Wray, R.J., Stryker, J.E., Winer, E. et al. Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations. J Canc Educ 22, 21–24 (2007). https://doi.org/10.1007/BF03174370

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