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

This study is currently recruiting participants.
Verified December 2011 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Mia Bergenmar, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01502254
First received: December 22, 2011
Last updated: December 29, 2011
Last verified: December 2011
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.


Estimated Enrollment: 175
Study Start Date: October 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502254

Contacts
Contact: Mia Bergenmar, PhD +46851773193 mia.bergenmar@ki.se

Locations
Sweden
Department of Oncology, Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Mia Bergenmar, PhD     +47851773193     mia.bergenmar@ki.se    
Department of Oncology, Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Mia Bergenmar, PhD     +46851773193     mia.bergenmar@ki.se    
Principal Investigator: Mia Bergenmar, PhD            
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:

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: December 29, 2011
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 May 19, 2013