NCT01502254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

4.3 years

First QC Date

December 22, 2011

Last Update Submit

February 11, 2014

Conditions

Cancer

Keywords

Informed consentCancer clinical trialsPatient informationKnowledgeQuestionnairePatient Eligible for a Phase II or III Cancer Clinical TrialScheduled Clinical Visit for Information About a Trial

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Study Arms (2)

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

audio recorded informationOTHER

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.

Copy of audio recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 18818068BACKGROUND

  • 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.

    PMID: 21109583BACKGROUND

  • 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.

    PMID: 24909376DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Mia Bergenmar, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 30, 2011

Study Start

October 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

SE(1)