Colorectal NeoplasmsNCT00765869
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening
A study testing Bowel cancer screening decision aid and Australian Government Bowel Cancer Screening booklet in people with Colorectal Neoplasms, run by University of Sydney at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing. Read more about this study
- Who is it for?
- Ages 55 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Bowel cancer screening decision aid and Australian Government Bowel Cancer Screening booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2008to Feb 2009
- 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 55 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 55-64 years
- Lower levels of education
- English as a main language spoken at home
- Average risk of bowel cancer
Who cannot join
- Higher levels of education
- Invitation to take part in bowel cancer screening in last two years
- Personal or strong family history of bowel cancer
- Had a bowel cancer screening test in the last two years
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Hunter Valley Research Foundation
Newcastle, New South Wales, 2293
Kirsten J McCaffery, PhD
About this study
Official title: A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.
Read the detailed description
Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. Decision aids (DAs) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. Their use in a wide range of clinical settings has increased dramatically. However, most DAs are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations.
This primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy.
There are three secondary aims of the study. First, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. Second, to identify participant's screening interest, intentions and behavior. Thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision.
- Conditions
- Colorectal Neoplasms
- Being tested
- Bowel cancer screening decision aid, Australian Government Bowel Cancer Screening booklet
- Keywords
- Decision support techniques
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel cancer screening decision aidOther
A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)
Bowel cancer screening decision aidOther
A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)
Australian Government Bowel Cancer Screening bookletOther
A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bowel cancer screening decision aid, DVD and Question Prompt List (QPL) Receives: Other: Bowel cancer screening decision aid |
| 2 | Experimental | Bowel cancer screening decision with DVD only Receives: Other: Bowel cancer screening decision aid |
| 3 | Active comparator | Australian Government Bowel Cancer Screening consumer information booklet Receives: Other: Australian Government Bowel Cancer Screening booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed choice
Measured: 2 weeks post intervention
Involvement in screening decision
Measured: 2 weeks post intervention
Secondary outcomes (10)
Anxiety
Measured: 2 weeks post intervention
Bowel cancer worry
Measured: 2 weeks post intervention
Decisional conflict
Measured: 2 weeks post intervention
Decision satisfaction
Measured: 2 weeks post intervention
Bowel cancer screening interest
Measured: 2 weeks post intervention
Bowel cancer screening intentions
Measured: 2 weeks post intervention
Screening behaviour
Measured: 2 weeks post intervention
Self reported bowel cancer symptoms
Measured: 2 weeks post intervention
Evaluation of intervention materials
Measured: 2 weeks post intervention
Influence of doctor on screening decision
Measured: 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008 (estimated)
- Study completionFeb 2009 (estimated)
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 Colorectal NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 555 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- McCaffery J Kirsten, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765869
- Sponsor's protocol ID
- HREC10403
- Other IDs
- ACTRN12608000011381
- Status last verified
- Oct 2008
- First submitted
- 1 Oct 2008
- Last updated
- 3 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith SK, Trevena L, Nutbeam D, Barratt A, McCaffery KJ. Information needs and preferences of low and high literacy consumers for decisions about colorectal cancer screening: utilizing a linguistic model. Health Expect. 2008 Jun;11(2):123-36. doi: 10.1111/j.1369-7625.2008.00489.x.
PubMed 18494957Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Legare F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6.
PubMed 38284415Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010 Oct 26;341:c5370. doi: 10.1136/bmj.c5370.
PubMed 20978060
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
- ClinicalTrials.gov ID
- NCT00765869
- Acronym / sponsor ID
- HREC10403
- Conditions
- Colorectal Neoplasms
- Keywords
- Decision support techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 555 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 3 Oct 2008 (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 evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.
Detailed description
Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. Decision aids (DAs) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. Their use in a wide range of clinical settings has increased dramatically. However, most DAs are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations.
This primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy.
There are three secondary aims of the study. First, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. Second, to identify participant's screening interest, intentions and behavior. Thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Bowel cancer screening decision aidBowel cancer screening decision aid, DVD and Question Prompt List (QPL) |
| 2 | Experimental | Other: Bowel cancer screening decision aidBowel cancer screening decision with DVD only |
| 3 | Active comparator | Other: Australian Government Bowel Cancer Screening bookletAustralian Government Bowel Cancer Screening consumer information booklet |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women aged 55-64 years
- Lower levels of education
- English as a main language spoken at home
- Average risk of bowel cancer
Key exclusion criteria (4 listed)
- Higher levels of education
- Invitation to take part in bowel cancer screening in last two years
- Personal or strong family history of bowel cancer
- Had a bowel cancer screening test in the last two years
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 |
|---|---|---|
| Bowel cancer screening decision aidA decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT) | Other | 1 |
| Bowel cancer screening decision aidA decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT) | Other | 2 |
| Australian Government Bowel Cancer Screening bookletA consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program | Other | 3 |
Primary outcome
Informed choice
Time frame: 2 weeks post intervention
Involvement in screening decision
Time frame: 2 weeks post intervention
10 secondary outcomes
Anxiety
Time frame: 2 weeks post intervention
Bowel cancer worry
Time frame: 2 weeks post intervention
Decisional conflict
Time frame: 2 weeks post intervention
Decision satisfaction
Time frame: 2 weeks post intervention
Bowel cancer screening interest
Time frame: 2 weeks post intervention
Bowel cancer screening intentions
Time frame: 2 weeks post intervention
Screening behaviour
Time frame: 2 weeks post intervention
Self reported bowel cancer symptoms
Time frame: 2 weeks post intervention
Evaluation of intervention materials
Time frame: 2 weeks post intervention
Influence of doctor on screening decision
Time frame: 2 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2008.
- Background: PubMed 18494957Smith SK, Trevena L, Nutbeam D, Barratt A, McCaffery KJ. Information needs and preferences of low and high literacy consumers for decisions about colorectal cancer screening: utilizing a linguistic model. Health Expect. 2008 Jun;11(2):123-36. doi: 10.1111/j.1369-7625.2008.00489.x.
- Derived from this study: PubMed 38284415Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Legare F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6.
- Derived from this study: PubMed 20978060Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010 Oct 26;341:c5370. doi: 10.1136/bmj.c5370.
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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.
McCaffery J Kirsten, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel cancer screening decision aid and Australian Government Bowel Cancer Screening booklet in people with Colorectal Neoplasms, run by University of Sydney at 1 site in Australia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 2008. 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 Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsten J McCaffery, PhD (+61 (0) 2 9351 7220, kirstenm@health.usyd.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed choice (time frame: 2 weeks post intervention). The study lists 2 primary outcomes in all. 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 NCT00765869, 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 3 Oct 2008.