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A randomised controlled trial to evaluate the effectiveness of a bowel cancer screening decision aid for adults with low literacy

A randomised controlled trial of a bowel cancer decision aid to support informed decision making among adults with low literacy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000011381
Acronym
Low literacy FOBT DA
Enrollment
600
Registered
2008-01-10
Start date
2008-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 probabilis

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.

Sponsors

Dr Kirsten McCaffery
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
55 Years to 64 Years
Healthy volunteers
Yes

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026