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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: audio recorded information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed in Swedish about a phase II or III clinical trial Signed a consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Copy of audio recording<br>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<br>* 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.<br>|
| No Intervention: No copy of audio recording<br>Patients in the control arm receive no copy of the audio recording. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. One reminder is sent to those not responding within two weeks. | The questionnaire is sent to patients within a week after consenting to the trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. One reminder is sent to those not responding within two weeks. | The questionnaire is sent to patients within a week after consenting to the trial. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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