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

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ClinicalTrials.gov Identifier: NCT01502254
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mia Bergenmar, Karolinska University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Other: audio recorded information Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information
Study Start Date : October 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mia Bergenmar, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01502254     History of Changes
Other Study ID Numbers: QuIC-3
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Mia Bergenmar, 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