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Related Experiment Videos

Proposing phase I studies: patients', relatives', nurses' and specialists' perceptions.

M Tomamichel1, H Jaime, A Degrate

  • 1Department of Psychosocial Care, Lugano, Switzerland.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|May 16, 2000
PubMed
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In phase I trials, providing information about investigational treatments is feasible and does not increase patient anxiety or depression. Patient and healthcare professional perceptions of information clarity were positive, though physician-patient communication could be improved.

Area of Science:

  • Clinical Oncology
  • Clinical Trial Design
  • Informed Consent Process

Background:

  • Previous studies focused on patient expectations and reasons for participation in phase I trials.
  • Prior research indicated adequate information quantity but insufficient attention to patients' emotional needs during informed consent.
  • A gap exists in understanding multi-stakeholder perceptions of informed consent and its impact on patient anxiety.

Purpose of the Study:

  • To compare perceptions of information provided during phase I trial informed consent among patients, relatives, research nurses, and investigators.
  • To assess the impact of this information on patients' anxiety and depression levels.

Main Methods:

  • Phase I trial participants underwent two interviews, with relatives, a research nurse, and the investigator present at the second interview.
Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

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  • Attendees completed questionnaires on reasons for participation and information quality (informative, emotional, interactive dimensions).
  • Patients completed the Hospital Anxiety and Depression (HAD) scale before and after the second interview.

    • Main Results:

    • Of 42 patients, 31 completed questionnaires. Patient benefit was the primary motivation for 59% of patients, versus 78% (nurse) and 86% (investigator).
    • All attendees found the information clear and sufficient. Investigators noted fewer patients felt at ease and expressed worries compared to nurse and relative assessments.
    • Patient anxiety and depression levels were not adversely affected by the information provided.

    Conclusions:

    • Informed consent for phase I investigational treatments is feasible and perceived as appropriate by patients, relatives, and healthcare professionals.
    • Appropriate information delivery does not exacerbate patient anxiety or depression.
    • Discrepancies in evaluating communication may stem from differing aims; innovative phase I designs could help bridge this gap.