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

February 11, 2014 updated by: Mia Bergenmar, Karolinska University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Department of Oncology, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed in Swedish about a phase II or III clinical trial
  • Signed a consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: 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.
NO_INTERVENTION: No copy of audio recording
Patients in the control arm receive no copy of the audio recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
The questionnaire is sent to patients within a week after consenting to the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Mia Bergenmar, PhD, Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (ESTIMATE)

December 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QuIC-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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