Patients’ Knowledge and Understanding of Cancer Clinical Trials – a Study of Audio Recorded Information

Overview

The purpose of this study is to test if cancer patients who are informed about, and offered participation in a cancer clinical trial, are more knowledgeable about cancer clinical trials if they have access to an audio recording of their information visit.

Full Title of Study: “Patients’ Knowledge and Understanding of Cancer Clinical Trials – a Randomised Study of Audio Recorded Information”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • Other: audio recorded information
    • Access to the audio recorded information about the clinical trial the patient was information about and asked to consider. A copy of the audio recording is given to the patients directly after the clinical visit.

Arms, Groups and Cohorts

  • Experimental: Copy of audio recording
    • Patients receive a copy of the audio recorded information about the clinical trial directly after the clinical visit. This makes it possible to repeat the information before a decision is made to participate in the clinical trial or not.
  • No Intervention: No copy of audio recording
    • Patients in the control arm receive no copy of the audio recording.

Clinical Trial Outcome Measures

Primary Measures

  • Patients’ knowledge about clinical trials measured by the questionnaire Quality of Informed Consent
    • Time Frame: The questionnaire is sent to patients within a week after consenting to the trial.
    • The questionnaire is sent to patients within a week after consenting to the trial. One reminder is sent to those not responding within two weeks.

Secondary Measures

  • Patients’ perceived understanding of clinical trials measured by the questionnaire Quality of Informed Consent
    • Time Frame: The questionnaire is sent to patients within a week after consenting to the trial.
    • The questionnaire is sent to patients within a week after consenting to the trial. One reminder is sent to those not responding within two weeks.

Participating in This Clinical Trial

Inclusion Criteria

  • Informed in Swedish about a phase II or III clinical trial
  • Signed a consent form

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mia Bergenmar, Principal Investigator – Karolinska University Hospital
  • Overall Official(s)
    • Mia Bergenmar, PhD, Principal Investigator, Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

References

Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008 Nov;44(17):2627-33. doi: 10.1016/j.ejca.2008.08.013. Epub 2008 Sep 23.

Bergenmar M, Johansson H, Wilking N. Levels of knowledge and perceived understanding among participants in cancer clinical trials – factors related to the informed consent procedure. Clin Trials. 2011 Feb;8(1):77-84. doi: 10.1177/1740774510384516. Epub 2010 Nov 25.

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