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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00765869
• Other study ID #: HREC10403
• Secondary ID: ACTRN12608000011
• Status: Unknown status
• Phase: N/A
• First received: October 1, 2008
• Last updated: October 2, 2008
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2008
• Source: University of Sydney
• Contact: Kirsten J McCaffery, PhD
• Phone: +61 (0) 2 9351 7220
• Email: kirstenm[@]health.usyd.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Unknown status
• Enrollment: 555
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Hunter Valley Research Foundation	Newcastle	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
University of Sydney	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Smith SK, Trevena L, Nutbeam D, Barratt A, McCaffery KJ. Information needs and preferences of low and high literacy consumers for decisions about colorectal cancer screening: utilizing a linguistic model. Health Expect. 2008 Jun;11(2):123-36. doi: 10.1111/j.1369-7625.2008.00489.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Informed choice		2 weeks post intervention
Primary	Involvement in screening decision		2 weeks post intervention
Secondary	Anxiety		2 weeks post intervention
Secondary	Bowel cancer worry		2 weeks post intervention
Secondary	Decisional conflict		2 weeks post intervention
Secondary	Decision satisfaction		2 weeks post intervention
Secondary	Bowel cancer screening interest		2 weeks post intervention
Secondary	Bowel cancer screening intentions		2 weeks post intervention
Secondary	Screening behaviour		2 weeks post intervention
Secondary	Self reported bowel cancer symptoms		2 weeks post intervention
Secondary	Evaluation of intervention materials		2 weeks post intervention
Secondary	Influence of doctor on screening decision		2 weeks post intervention