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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Sydney.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00765869
First received: October 1, 2008
Last updated: October 2, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
 Other: Bowel cancer screening decision aid
Other: Australian Government Bowel Cancer Screening booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Informed choice [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Involvement in screening decision [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Bowel cancer worry [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Decisional conflict [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Decision satisfaction [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Bowel cancer screening interest [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Bowel cancer screening intentions [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Screening behaviour [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Self reported bowel cancer symptoms [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Evaluation of intervention materials [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]
  • Influence of doctor on screening decision [ Time Frame: 2 weeks post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 555
Study Start Date: July 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765869

Contacts
Contact: Kirsten J McCaffery, PhD +61 (0) 2 9351 7220 kirstenm@health.usyd.edu.au
Contact: Sian K Smith, BSc (Hons) +61 (0) 2 9351 7220 sians@health.usyd.edu.au

Locations
Australia, New South Wales
Hunter Valley Research Foundation Recruiting
Newcastle, New South Wales, Australia, 2293
Principal Investigator: Kirsten J McCaffery, PhD            
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: McCaffery J Kirsten, PhD University of Sydney
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Kirsten McCaffery, Screening and Test Evaluation program,University of Sydney
ClinicalTrials.gov Identifier: NCT00765869     History of Changes
Other Study ID Numbers: HREC10403, ACTRN12608000011381
Study First Received: October 1, 2008
Last Updated: October 2, 2008
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by University of Sydney:
Decision support techniques

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 17, 2013