CancerNCT01502254
Patients' Knowledge and Understanding of Cancer Clinical Trials - a Study of Audio Recorded Information
A study testing audio recorded information in people with Cancer, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- audio recorded information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed in Swedish about a phase II or III clinical trial
- Signed a consent form
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Oncology, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- audio recorded information
- Keywords
- 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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: audio recorded information |
| No copy of audio recording | No intervention | Patients in the control arm receive no copy of the audio recording. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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. One reminder is sent to those not responding within two weeks.
Measured: The questionnaire is sent to patients within a week after consenting to the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startOct 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Bergenmar, Karolinska University Hospital
- Investigators
- Mia Bergenmar, PhD, Principal investigator, Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502254
- Sponsor's protocol ID
- QuIC-3
- Status last verified
- Feb 2014
- First submitted
- 22 Dec 2011
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18818068Bergenmar 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.
PubMed 21109583Bergenmar 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.
PubMed 24909376
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information
- ClinicalTrials.gov ID
- NCT01502254
- Acronym / sponsor ID
- QuIC-3
- Conditions
- Cancer
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copy of audio recording | Experimental | Other: audio recorded informationPatients 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. |
| No copy of audio recording | No intervention | –Patients in the control arm receive no copy of the audio recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed in Swedish about a phase II or III clinical trial
- Signed a consent form
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audio recorded informationAccess 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. | Other | Copy of audio recording |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Background: PubMed 18818068Bergenmar 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.
- Background: PubMed 21109583Bergenmar 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.
- Derived from this study: PubMed 24909376Bergenmar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mia Bergenmar, PhD principal investigator
Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing audio recorded information in people with Cancer, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502254, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.