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Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology

Abstract

Purpose

The aim of the present study was to explore (1) informed consent (IC) representations, level of understanding, needs, and factors that influence the willingness of cancer patients to participate in randomized controlled trials (RCTs) (phase I) and (2) representations, experiences, and critical issues of physicians involved in the same process (phase II).

Methods

Semi-structured interviews were conducted with 20 cancer patients who had been asked to enroll in a phase II/III RCT (phase I). Two focus groups were conducted with 13 physicians enrolled in the same process (phase II). The content produced was analyzed through a thematic analysis.

Results

The themes that emerged in the first phase I were grouped into six categories: IC representation, randomization, experimentation, meeting with the physician, factors that influence the willingness to participate, and trial participants’ needs. The themes emerged in the phase II were grouped into four: IC representation, critical issues of the IC, relationship, and recruitment of trial participants. Each theme is articulated into sub-themes and deeply discussed.

Conclusion

This study highlights (1) the gap between what is ethically demanded in a RCT consultation and the reality of the situation and (2) the difference in perceptions between patients and physicians with reference to the meaning, objectives, and level of understanding of IC.

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Data availability

All transcripts and qualitative analyzes are available in Italian. It is sufficient to write to the corresponding author to have them.

Code availability

Not applicable.

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Acknowledgements

We sincerely thank the Ethics Committee of INT for their valuable suggestions and encouragement to carry out the study. We also thank the anonymous referee for the valuable suggestions provided and Prenay Agarwal for the English revision.

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Affiliations

Authors

Contributions

LG, MG, PC, and CB designed the study and critically revised the paper; SA, DF, and LG wrote the article; SA, LG, and MS performed the analysis; MS, MG, and EB contributed to data collection and critically revised the paper. DF also revised the English. All authors had full access to data and are responsible for the integrity and the accuracy of the data.

Corresponding author

Correspondence to Sara Alfieri.

Ethics declarations

Ethics approval

The study was approved by the Ethics Committee of INT with number of acceptance 135/12.

Consent to participate and consent for publication

All participants were given adequate informed consent both verbally and through the specific form authorized by the Ethics Committee.

Conflict of interest

The authors declare no competing interests.

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Gangeri, L., Alfieri, S., Greco, M. et al. Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology. Support Care Cancer (2021). https://doi.org/10.1007/s00520-021-06599-7

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Keywords

  • Ethics
  • Informed consent
  • Oncology
  • Patients’ experiences
  • Physicians’ experiences
  • Randomized controlled trials