Cancer
Conditions
Keywords
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
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.
Interventions
OTHERaudio 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.
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed in Swedish about a phase II or III clinical trial * Signed a consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' knowledge about clinical trials measured by the questionnaire Quality of Informed Consent | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Sweden
Outcome results
None listed