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

Not Applicable
Conditions
Colorectal Neoplasms
Interventions
Other: Bowel cancer screening decision aid
Other: Australian Government Bowel Cancer Screening booklet
Registration Number
NCT00765869
Lead Sponsor
University of Sydney
Brief 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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
555
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Bowel cancer screening decision aidBowel cancer screening decision aid, DVD and Question Prompt List (QPL)
2Bowel cancer screening decision aidBowel cancer screening decision with DVD only
3Australian Government Bowel Cancer Screening bookletAustralian Government Bowel Cancer Screening consumer information booklet
Primary Outcome Measures
NameTimeMethod
Informed choice2 weeks post intervention
Involvement in screening decision2 weeks post intervention
Secondary Outcome Measures
NameTimeMethod
Anxiety2 weeks post intervention
Bowel cancer worry2 weeks post intervention
Decisional conflict2 weeks post intervention
Decision satisfaction2 weeks post intervention
Bowel cancer screening interest2 weeks post intervention
Bowel cancer screening intentions2 weeks post intervention
Screening behaviour2 weeks post intervention
Self reported bowel cancer symptoms2 weeks post intervention
Evaluation of intervention materials2 weeks post intervention
Influence of doctor on screening decision2 weeks post intervention

Trial Locations

Locations (1)

Hunter Valley Research Foundation

🇦🇺

Newcastle, New South Wales, Australia

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