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

University of Sydney

Status: Unknown

Conditions: Colorectal Neoplasms

Treatments: Other: Australian Government Bowel Cancer Screening booklet; Other: Bowel cancer screening decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT00765869

ACTRN12608000011381

HREC10403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 555 estimated patients

Sex: All

Ages: 55 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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555 participants in 3 patient groups

1

Experimental group

Description:

Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)

Treatment:

Other: Bowel cancer screening decision aid

Other: Bowel cancer screening decision aid

2

Experimental group

Description:

Bowel cancer screening decision with DVD only

Treatment:

Other: Bowel cancer screening decision aid

Other: Bowel cancer screening decision aid

3

Active Comparator group

Description:

Australian Government Bowel Cancer Screening consumer information booklet

Treatment:

Other: Australian Government Bowel Cancer Screening booklet