Clinical trial NCT00765869: Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening
Official title: A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Decision support techniques
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2008-10-03
Enrollment: 555
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Informed choice
timeFrame: 2 weeks post intervention
measure: Involvement in screening decision
timeFrame: 2 weeks post intervention
Secondary outcomes:
measure: Anxiety
timeFrame: 2 weeks post intervention
measure: Bowel cancer worry
timeFrame: 2 weeks post intervention
measure: Decisional conflict
timeFrame: 2 weeks post intervention
measure: Decision satisfaction
timeFrame: 2 weeks post intervention
measure: Bowel cancer screening interest
timeFrame: 2 weeks post intervention
measure: Bowel cancer screening intentions
timeFrame: 2 weeks post intervention
measure: Screening behaviour
timeFrame: 2 weeks post intervention
measure: Self reported bowel cancer symptoms
timeFrame: 2 weeks post intervention
measure: Evaluation of intervention materials
timeFrame: 2 weeks post intervention
measure: Influence of doctor on screening decision
timeFrame: 2 weeks post intervention
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Hunter Valley Research Foundation
state: New South Wales
Study officials:
affiliation: University of Sydney
name: McCaffery J Kirsten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010 Oct 26;341:c5370. doi: 10.1136/bmj.c5370.