Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Other: Bowel cancer screening decision aid
* Other: Bowel cancer screening decision aid
* Other: Australian Government Bowel Cancer Screening booklet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bowel cancer screening decision aid, DVD and Question Prompt List (QPL) | Other: Bowel cancer screening decision aid<br>* 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)<br>|
| Experimental: 2<br>Bowel cancer screening decision with DVD only | Other: Bowel cancer screening decision aid<br>* 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)<br>|
| Active Comparator: 3<br>Australian Government Bowel Cancer Screening consumer information booklet | Other: Australian Government Bowel Cancer Screening booklet<br>* A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Informed choice |  | 2 weeks post intervention | 
| Involvement in screening decision |  | 2 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety |  | 2 weeks post intervention | 
| Bowel cancer worry |  | 2 weeks post intervention | 
| Decisional conflict |  | 2 weeks post intervention | 
| Decision satisfaction |  | 2 weeks post intervention | 
| Bowel cancer screening interest |  | 2 weeks post intervention | 
| Bowel cancer screening intentions |  | 2 weeks post intervention | 
| Screening behaviour |  | 2 weeks post intervention | 
| Self reported bowel cancer symptoms |  | 2 weeks post intervention | 
| Evaluation of intervention materials |  | 2 weeks post intervention | 
| Influence of doctor on screening decision |  | 2 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision support techniques