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NCT01502254 Clinical Trial

Patients' Knowledge and Understanding of Cancer Clinical Trials - a Study of Audio Recorded Information

Cancer Clinical Trial

Official title:
Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01502254
Other study ID # QuIC-3
Secondary ID
Status Completed
Phase N/A
First received December 22, 2011
Last updated February 11, 2014
Start date October 2008
Est. completion date January 2013

Study information
Verified date February 2014
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed in Swedish about a phase II or III clinical trial

- Signed a consent form

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Sweden Department of Oncology, Karolinska University Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Patients' knowledge about clinical trials measured by the questionnaire Quality of Informed Consent 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. The questionnaire is sent to patients within a week after consenting to the trial. No
Secondary Patients' perceived understanding of clinical trials measured by the questionnaire Quality of Informed Consent 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. The questionnaire is sent to patients within a week after consenting to the trial. No
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