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

October 2, 2008 updated by: University of Sydney

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

555

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2293
        • Recruiting
        • Hunter Valley Research Foundation
        • Principal Investigator:
          • Kirsten J McCaffery, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)
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)
Experimental: 2
Bowel cancer screening decision with DVD only
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)
Active Comparator: 3
Australian Government Bowel Cancer Screening consumer information booklet
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Informed choice
Time Frame: 2 weeks post intervention
2 weeks post intervention
Involvement in screening decision
Time Frame: 2 weeks post intervention
2 weeks post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety
Time Frame: 2 weeks post intervention
2 weeks post intervention
Bowel cancer worry
Time Frame: 2 weeks post intervention
2 weeks post intervention
Decisional conflict
Time Frame: 2 weeks post intervention
2 weeks post intervention
Decision satisfaction
Time Frame: 2 weeks post intervention
2 weeks post intervention
Bowel cancer screening interest
Time Frame: 2 weeks post intervention
2 weeks post intervention
Bowel cancer screening intentions
Time Frame: 2 weeks post intervention
2 weeks post intervention
Screening behaviour
Time Frame: 2 weeks post intervention
2 weeks post intervention
Self reported bowel cancer symptoms
Time Frame: 2 weeks post intervention
2 weeks post intervention
Evaluation of intervention materials
Time Frame: 2 weeks post intervention
2 weeks post intervention
Influence of doctor on screening decision
Time Frame: 2 weeks post intervention
2 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: McCaffery J Kirsten, PhD, University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 3, 2008

Last Update Submitted That Met QC Criteria

October 2, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC10403
  • ACTRN12608000011381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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