A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sydney
- Enrollment
- 555
- Locations
- 1
- Primary Endpoint
- Informed choice
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 55 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)
Intervention: Bowel cancer screening decision aid (Other)
2
Bowel cancer screening decision with DVD only
Intervention: Bowel cancer screening decision aid (Other)
3
Australian Government Bowel Cancer Screening consumer information booklet
Intervention: Australian Government Bowel Cancer Screening booklet (Other)
Outcomes
Primary Outcomes
Informed choice
Time Frame: 2 weeks post intervention
Involvement in screening decision
Time Frame: 2 weeks post intervention
Secondary Outcomes
- 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)