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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00765869
Enrollment
555
Registered
2008-10-03
Start date
2008-07-31
Completion date
2009-02-28
Last updated
2008-10-03

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

Conditions

Colorectal Neoplasms

Keywords

Decision support techniques

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.

Interventions

OTHERBowel cancer screening decision aid

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)

OTHERAustralian Government Bowel Cancer Screening booklet

A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program

Sponsors

National Health and Medical Research Council, Australia
CollaboratorOTHER
University of Sydney
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frame
Informed choice2 weeks post intervention
Involvement in screening decision2 weeks post intervention

Secondary

MeasureTime frame
Decisional conflict2 weeks post intervention
Decision satisfaction2 weeks post intervention
Bowel cancer screening interest2 weeks post intervention
Bowel cancer screening intentions2 weeks post intervention
Anxiety2 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
Screening behaviour2 weeks post intervention
Bowel cancer worry2 weeks post intervention

Countries

Australia

Contacts

Primary ContactKirsten J McCaffery, PhD
kirstenm@health.usyd.edu.au+61 (0) 2 9351 7220
Backup ContactSian K Smith, BSc (Hons)
sians@health.usyd.edu.au+61 (0) 2 9351 7220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026