- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00765869
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening
A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kirsten J McCaffery, PhD
- Phone Number: +61 (0) 2 9351 7220
- Email: kirstenm@health.usyd.edu.au
Study Contact Backup
- Name: Sian K Smith, BSc (Hons)
- Phone Number: +61 (0) 2 9351 7220
- Email: sians@health.usyd.edu.au
Study Locations
-
-
New South Wales
-
Newcastle, New South Wales, Australia, 2293
- Recruiting
- Hunter Valley Research Foundation
-
Principal Investigator:
- Kirsten J McCaffery, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged 55-64 years
- Lower levels of education
- English as a main language spoken at home
- Average risk of bowel cancer
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)
|
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)
|
Experimental: 2
Bowel cancer screening decision with DVD only
|
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)
|
Active Comparator: 3
Australian Government Bowel Cancer Screening consumer information booklet
|
A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Informed choice
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Involvement in screening decision
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anxiety
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Bowel cancer worry
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Decisional conflict
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Decision satisfaction
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Bowel cancer screening interest
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Bowel cancer screening intentions
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Screening behaviour
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Self reported bowel cancer symptoms
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Evaluation of intervention materials
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Influence of doctor on screening decision
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: McCaffery J Kirsten, PhD, University of Sydney
Publications and helpful links
General 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.
- Smith 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC10403
- ACTRN12608000011381
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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