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

Not Applicable

• Conditions: Colorectal Neoplasms

• 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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-02
• Last Update Submitted: 2008-10-02
• Study First Posted: 2008-10-03
• Last Update Posted: 2008-10-03
• Primary Completion: 2008-12
• Study Completion: 2009-02

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

Primary Outcome Measures

Name	Time	Method
Informed choice	2 weeks post intervention
Involvement in screening decision	2 weeks post intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hunter Valley Research Foundation; 🇦🇺 Newcastle, New South Wales, Australia