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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mia Bergenmar, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT01502254

First received: December 22, 2011

Last updated: February 11, 2014

Last verified: February 2014

History of Changes

Purpose

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.

Condition	Intervention
Cancer	Other: audio recorded information


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome 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. ] [ Designated as safety issue: No ]
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 Outcome 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. ] [ Designated as safety issue: No ]
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.


Enrollment:	130
Study Start Date:	October 2008
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
No Intervention: No copy of audio recording Patients in the control arm receive no copy of the audio recording.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502254

Locations


Sweden
Department of Oncology, Karolinska University Hospital
Stockholm, Sweden, 17176

Sponsors and Collaborators

Karolinska University Hospital

Investigators


Principal Investigator:	Mia Bergenmar, PhD	Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

More Information

Publications:

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.


Responsible Party:	Mia Bergenmar, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT01502254 History of Changes
Other Study ID Numbers:	QuIC-3
Study First Received:	December 22, 2011
Last Updated:	February 11, 2014
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:


Informed consent Cancer clinical trials Patient information Knowledge	Questionnaire Patient Eligible for a Phase II or III Cancer Clinical Trial Scheduled Clinical Visit for Information About a Trial

ClinicalTrials.gov processed this record on February 27, 2015

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