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

NCT ID: NCT01502254

Last Updated: 2014-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-01-31

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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No copy of audio recording

Patients in the control arm receive no copy of the audio recording.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

audio recorded information

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed in Swedish about a phase II or III clinical trial
* Signed a consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mia Bergenmar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mia Bergenmar, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

Locations

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Department of Oncology, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 18818068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21109583 (View on PubMed)

Bergenmar M, Johansson H, Wilking N, Hatschek T, Brandberg Y. Audio-recorded information to patients considering participation in cancer clinical trials - a randomized study. Acta Oncol. 2014 Sep;53(9):1197-204. doi: 10.3109/0284186X.2014.921726. Epub 2014 Jun 9.

Reference Type DERIVED
PMID: 24909376 (View on PubMed)

Other Identifiers

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QuIC-3

Identifier Type: -

Identifier Source: org_study_id

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