Patients' Knowledge and Understanding of Cancer Clinical Trials - a Study of Audio Recorded Information
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01502254 |
Recruitment Status
:
Completed
First Posted
: December 30, 2011
Last Update Posted
: February 12, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Other: audio recorded information | Not Applicable |
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 |
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.
|
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed in Swedish about a phase II or III clinical trial
- Signed a consent form

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
Sweden | |
Department of Oncology, Karolinska University Hospital | |
Stockholm, Sweden, 17176 |
Principal Investigator: | Mia Bergenmar, PhD | Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden |
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 |