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Trial registered on ANZCTR


Registration number
ACTRN12608000011381
Ethics application status
Approved
Date submitted
8/01/2008
Date registered
10/01/2008
Date last updated
2/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate the effectiveness of a bowel cancer screening decision aid for adults with low literacy
Scientific title
A randomised controlled trial of a bowel cancer decision aid to support informed decision making among adults with low literacy
Universal Trial Number (UTN)
Trial acronym
Low literacy FOBT DA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 2675 0
Condition category
Condition code
Cancer 2798 2798 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 2799 2799 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A paper-based decision aid (with and without a question prompt list), audio visual DVD which had been specifically designed for adults with low education and literacy, who are making decisions about bowel cancer screening (using the Faecal Occult Blood test). The decision aid (a 33-page booklet) covers information provided by the Australian Commonwealth screening booklet, but is presented in a different format using simplified text and visual cues. The decision aid includes additional probabilistic information on cumulative FOBT outcomes over 10 years and a personal worksheet for people to complete to help them decide whether to do the screening test. about doing the screening test. We decided to produce an audio-visual DVD to accompany the text-based booklet and improve the accessibility of the information for adults with very basic literacy skills. The DVD lasted for about 20 minutes.

Participants will receive the intervention (decision aid and DVD) after they have completed a baseline telephone survey. The intervention package will be sent directly to people at home which means they have the choice of reading the booklet or watching the DVD, or both. They will be telephoned 2-3 weeks later to complete a follow-up survey.
Intervention code [1] 2417 0
Other interventions
Comparator / control treatment
Standard Australian Commonwealth Bowel Cancer Screening written information booklet which is currently posted to adults who are invited to take part in the National Bowel Cancer Screening program
Control group
Active

Outcomes
Primary outcome [1] 3686 0
Informed decision making (attitudes towards bowel cancer screening, knowledge about screening and screening behaviour). This will be measured using a telephone survey.
Timepoint [1] 3686 0
Attitudes and understanding of bowel cancer screening will be measured 2-3 weeks after intervention commencement
Screening behaviour will be cross checked with the laboratory, 3 months after intervention commencement
Primary outcome [2] 3687 0
Involvement preferences in screening decisions. This will be measured using a telephone survey.
Timepoint [2] 3687 0
2-3 weeks post intervention
Secondary outcome [1] 6215 0
Anxiety. This will be measured using a telephone survey.
Timepoint [1] 6215 0
2-3 weeks after the intervention
Secondary outcome [2] 6216 0
Bowel cancer worry. This will be measured using a telephone survey.
Timepoint [2] 6216 0
2-3 weeks after the intervention
Secondary outcome [3] 6217 0
Bowel cancer screening interest. This will be measured using a telephone survey.
Timepoint [3] 6217 0
2-3 weeks after the intervention
Secondary outcome [4] 6218 0
Bowel cancer screening intentions. This will be measured using a telephone survey.
Timepoint [4] 6218 0
2-3 weeks after the intervention
Secondary outcome [5] 6219 0
Decisional conflict. This will be measured using a telephone survey.
Timepoint [5] 6219 0
2-3 weeks after the intervention
Secondary outcome [6] 6220 0
Decision satisfaction. This will be measured using a telephone survey.
Timepoint [6] 6220 0
2-3 weeks after the intervention
Secondary outcome [7] 6221 0
Evaluation of materials (written information & DVD). This will be measured using telephone survey questions devised by the research team.
Timepoint [7] 6221 0
2-3 weeks after the intervention
Secondary outcome [8] 6222 0
Use of different components (DVD, Question Prompt List). This will be measured using telephone survey questions devised by the research team.
Timepoint [8] 6222 0
2-3 weeks after the intervention
Secondary outcome [9] 6223 0
Influence of doctor on participant's bowel cancer screening decision. This will be measured using telephone survey questions devised by the research team.
Timepoint [9] 6223 0
2-3 weeks after the intervention

Eligibility
Key inclusion criteria
Men and Women aged 55-64 years
Low levels of education (no formal educational qualifications, intermediate certificate (or equivalent), trade/apprenticeship (e.g. hairdresser, carpenter)
English as main language spoken at home
Average risk of bowel cancer (no family history or weak family history of bowel cancer)
Minimum age
55 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Respondents who attained higher school or leaving certificate (or equivalent), TAFE certificate, diploma, University degree or higher will not be able to take part in the trial
Respondents who have invited to and or already taking part in the National Bowel Cancer Screening program
Respondents who have bowel cancer or had a bowel condition in the last 12 months which is currently under treatment
Respondents who have had a bowel cancer screening test in the last 2 years (this includes: faecal occult blood test, colonoscopy, flexible sigmoidoscopy)
Respondents with a strong family history of bowel cancer

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Please replace "Participants will be randomized to group A or B study arms using random permuted blocks within gender strata" with "Participants were randomised to one of three trial arms using random permuted blocks within gender strata.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to one of three study arms using random permuted blocks within gender strata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 711 0
2148
Recruitment postcode(s) [2] 714 0
2310
Recruitment postcode(s) [3] 715 0
2348
Recruitment postcode(s) [4] 716 0
2421
Recruitment postcode(s) [5] 712 0
2460
Recruitment postcode(s) [6] 710 0
2564
Recruitment postcode(s) [7] 717 0
2678
Recruitment postcode(s) [8] 709 0
2774
Recruitment postcode(s) [9] 713 0
2870

Funding & Sponsors
Funding source category [1] 2937 0
Government body
Name [1] 2937 0
National Health & Medical Research Council
Address [1] 2937 0
GPO Box 1421
Canberra ACT 2601
Country [1] 2937 0
Australia
Primary sponsor type
Individual
Name
Dr Kirsten McCaffery
Address
Screening and Test Evaluation Program
School of Public Health
Edward Ford Building (A27)
Room 301F
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 2651 0
Other Collaborative groups
Name [1] 2651 0
Screening and Test Evaluation Program
Address [1] 2651 0
Screening and Test Evaluation Program
School of Public Health
Edward Ford Building (A27)
University of Sydney
NSW 2006
Country [1] 2651 0
Australia
Other collaborator category [1] 122 0
Individual
Name [1] 122 0
Dr Lyndal Trevena
Address [1] 122 0
School of Public Health
Edward Ford Building (A27)
Room 321B
University of Sydney
NSW 2006
Country [1] 122 0
Australia
Other collaborator category [2] 123 0
Individual
Name [2] 123 0
Associate Professor Alexandra Barratt
Address [2] 123 0
School of Public Health
Edward Ford Building (A27)
Room 323A
University of Sydney
NSW 2006
Country [2] 123 0
Australia
Other collaborator category [3] 124 0
Individual
Name [3] 124 0
Professor Don Nutbeam
Address [3] 124 0
A14- Quadrangle
University of Sydney
NSW 2006
Country [3] 124 0
Australia
Other collaborator category [4] 125 0
Individual
Name [4] 125 0
Professor Judy Simpson
Address [4] 125 0
School of Public Health
Edward Ford Building (A27)
Room 301A
University of Sydney
NSW 2006
Country [4] 125 0
Australia
Other collaborator category [5] 625 0
Individual
Name [5] 625 0
Sian Smith
Address [5] 625 0
School of Public Health, Edward Ford Bldg (A27), Room 126A, University of Sydney, NSW 2006
Country [5] 625 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4882 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 4882 0
Human Research Ethics Committee
Main Quad (A14)
University of Sydney
NSW 2006
Ethics committee country [1] 4882 0
Australia
Date submitted for ethics approval [1] 4882 0
Approval date [1] 4882 0
15/10/2007
Ethics approval number [1] 4882 0
10403

Summary
Brief summary
This is a study to evaluate the effectiveness of a new decision aid for bowel cancer screening, for adults with low literacy levels.

Participants are eligible to participate if they:
- are aged 55–64 years
- have lower levels of education
- are at average or slightly above average risk of bowel cancer.

Trial details

Eligible participants will invited via telephone to take part in the trial. Those who consent will then be randomly divided into three groups. One group will receive a written decision aid (plus DVD and Question Prompt list) specifically designed for adults with low education and literacy, who are making decisions about bowel cancer screening. The second group will receive the written decision aid (+ DVD) without question prompt list, and the third group will receive the standard government consumer information. Both groups will receive a bowel cancer screening Faecal Occult Blood test (FOBT) kit and instructions. Participants will be telephoned 2–3 weeks later to complete a follow-up survey. At 3 months, we will record whether participant completed the screening test by checking against the laboratory records.



This study aims to evaluate the extent to which a written decision aid tailored for adults with low levels of literacy can increase understanding of bowel cancer screening and promote informed decision making.
Trial website
Trial related presentations / publications
Smith SK, Trevena LJ, Barratt A, Simpson J, Nutbeam D, McCaffery KJ. Design and preliminary evaluation of a bowel cancer screening decision aid for adults with low literacy. Patient Education and Counselling, accepted February 2009. Health literacy special issue.
Public notes

Contacts
Principal investigator
Name 28276 0
Address 28276 0
Country 28276 0
Phone 28276 0
Fax 28276 0
Email 28276 0
Contact person for public queries
Name 11433 0
Sian Smith
Address 11433 0
Screening and Test Evaluation Program
School of Public Health
Edward Ford Bldg (A27)
Room 126A
University of Sydney
NSW 2006
Country 11433 0
Australia
Phone 11433 0
+61 2 93517186
Fax 11433 0
+61 2 93515049
Email 11433 0
sians@health.usyd.edu.au
Contact person for scientific queries
Name 2361 0
Dr Kirsten McCaffery
Address 2361 0
Screening and Test Evaluation Program
School of Public Health
Edward Ford Bldg (A27)
Room 301F
University of Sydney
NSW 2006
Country 2361 0
Australia
Phone 2361 0
+61 2 93517220
Fax 2361 0
+61 2 93515049
Email 2361 0
kirstenm@health.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary