NCT01502254
Completed
Not Applicable
Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information
Karolinska University Hospital1 site in 1 country130 target enrollmentStarted: October 2008Last updated:
ConditionsCancer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska University Hospital
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Patients' knowledge about clinical trials measured by the questionnaire Quality of Informed Consent
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed in Swedish about a phase II or III clinical trial
- •Signed a consent form
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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.)
Investigators
Mia Bergenmar
Principal Investigator
Karolinska University Hospital
Study Sites (1)
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