Patients' Knowledge and Understanding of Cancer Clinical... | NCT01502254 | Trialant

Patients' Knowledge and Understanding of Cancer Clinical... | NCT01502254 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Copy of audio recording	Experimental	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
No copy of audio recording	No Intervention	Patients in the control arm receive no copy of the audio recording.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
audio recorded information	Other	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Mia Bergenmar, PhD	Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18818068	Background	Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008 Nov;44(17):2627-33. doi: 10.1016/j.ejca.2008.08.013. Epub 2008 Sep 23.
21109583	Background	Bergenmar M, Johansson H, Wilking N. Levels of knowledge and perceived understanding among participants in cancer clinical trials - factors related to the informed consent procedure. Clin Trials. 2011 Feb;8(1):77-84. doi: 10.1177/1740774510384516. Epub 2010 Nov 25.