Colorectal Cancer ScreeningNCT01250015
Does Numerical And Pictorial Information On Risk And Benefit Affects The Uptake Of Colorectal Cancer Screening?
An observational study of Colorectal Cancer Screening, run by County Durham and Darlington NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To establish whether provision of numerical data, framed as event rates and illustrated by pictograms, and including figures for all-cause mortality, affects subjects' attitudes to colorectal cancer (CRC) screening. Design and Intervention. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Sep 2008
- Phase
- Observational
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects attending GP and hospital outpatients
Who may be able to join
- Age 60 - 70
- -
Who cannot join
- No previous cancer or previous colonoscopy Not able to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Darlington Memorial Hospital
Darlington, Co Durham, dl3 6hxl
About this study
Official title: THE RESULTS OF A RANDOMISED CONTROLLED QUESTIONNAIRE-BASED TRIAL ON WHETHER PROVISION OF NUMERICAL AND PICTORIAL INFORMATION ON RISK AND BENEFIT AFFECTS THE UPTAKE OF COLORECTAL CANCER SCREENING?
To establish whether provision of numerical data, framed as event rates and illustrated by pictograms, and including figures for all-cause mortality, affects subjects' attitudes to colorectal cancer (CRC) screening.
Design and Intervention. Randomised questionnaire and telephone study comparing the responses of a control group given the standard National Health Service (NHS) CRC screening information with the responses of an intervention group given the same information but enhanced with additional numerical and pictorial information.
Setting
- Conditions
- Colorectal Cancer Screening
- Keywords
- colorectal cancer, consent, screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | given standard nhs advice leaflet | |
| interventional | given standard nhs advice leaflet with numerical information and pictograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the two groups' overall wish to be screened
The study compared the two groups' overall wish to be screened as recorded by questionnaire
Measured: 1 year
Secondary outcomes (1)
Impact of different summary points on subject's desire to be screened
The impact of each of the 6 summary points in the NHS information leaflet on the subject's desire to be screened depending on whether or not they were enhanced by numerical and pictorial information, the summary point that most influenced their decision on whether to be screened; and the views of the intervention group on the numerical and pictorial information provided
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- County Durham and Darlington NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Internal funding Local Gastroenterology Research fund (Questionnaire only study)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250015
- Sponsor's protocol ID
- 1
- Other IDs
- CDDFT (UK), CDDFT, UK
- Status last verified
- Mar 2008
- First submitted
- 29 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE RESULTS OF A RANDOMISED CONTROLLED QUESTIONNAIRE-BASED TRIAL ON WHETHER PROVISION OF NUMERICAL AND PICTORIAL INFORMATION ON RISK AND BENEFIT AFFECTS THE UPTAKE OF COLORECTAL CANCER SCREENING?
- ClinicalTrials.gov ID
- NCT01250015
- Acronym / sponsor ID
- 1
- Conditions
- Colorectal Cancer Screening
- Keywords
- colorectal cancer, consent, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- County Durham and Darlington NHS Foundation TrustOther government
- Collaborators
- Internal funding Local Gastroenterology Research fund (Questionnaire only study)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Nov 2010 (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.
To establish whether provision of numerical data, framed as event rates and illustrated by pictograms, and including figures for all-cause mortality, affects subjects' attitudes to colorectal cancer (CRC) screening.
Design and Intervention. Randomised questionnaire and telephone study comparing the responses of a control group given the standard National Health Service (NHS) CRC screening information with the responses of an intervention group given the same information but enhanced with additional numerical and pictorial information.
Setting
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –given standard nhs advice leaflet |
| interventional | – | –given standard nhs advice leaflet with numerical information and pictograms |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects attending GP and hospital outpatients
Key inclusion criteria (2 listed)
- Age 60 - 70
- -
Key exclusion criteria (1 listed)
- No previous cancer or previous colonoscopy Not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the two groups' overall wish to be screened
Time frame: 1 year
The study compared the two groups' overall wish to be screened as recorded by questionnaire
1 secondary outcome
Impact of different summary points on subject's desire to be screened
Time frame: 1 year
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 30 Nov 2010.
- CDDFT, NHS, UKLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Screening, run by County Durham and Darlington NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 30 Nov 2010. 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 United Kingdom. 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?
Comparison of the two groups' overall wish to be screened (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2010.