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

Primary Purpose

Colorectal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Bowel cancer screening decision aid
Bowel cancer screening decision aid
Australian Government Bowel Cancer Screening booklet
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Decision support techniques

Eligibility Criteria

55 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Hunter Valley Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

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

Bowel cancer screening decision with DVD only

Australian Government Bowel Cancer Screening consumer information booklet

Outcomes

Primary Outcome Measures

Informed choice
Involvement in screening decision

Secondary Outcome Measures

Anxiety
Bowel cancer worry
Decisional conflict
Decision satisfaction
Bowel cancer screening interest
Bowel cancer screening intentions
Screening behaviour
Self reported bowel cancer symptoms
Evaluation of intervention materials
Influence of doctor on screening decision

Full Information

First Posted
October 1, 2008
Last Updated
October 2, 2008
Sponsor
University of Sydney
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00765869
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sydney
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Decision support techniques

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
555 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)
Arm Title
2
Arm Type
Experimental
Arm Description
Bowel cancer screening decision with DVD only
Arm Title
3
Arm Type
Active Comparator
Arm Description
Australian Government Bowel Cancer Screening consumer information booklet
Intervention Type
Other
Intervention Name(s)
Bowel cancer screening decision aid
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Bowel cancer screening decision aid
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Australian Government Bowel Cancer Screening booklet
Intervention Description
A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program
Primary Outcome Measure Information:
Title
Informed choice
Time Frame
2 weeks post intervention
Title
Involvement in screening decision
Time Frame
2 weeks post intervention
Secondary Outcome Measure Information:
Title
Anxiety
Time Frame
2 weeks post intervention
Title
Bowel cancer worry
Time Frame
2 weeks post intervention
Title
Decisional conflict
Time Frame
2 weeks post intervention
Title
Decision satisfaction
Time Frame
2 weeks post intervention
Title
Bowel cancer screening interest
Time Frame
2 weeks post intervention
Title
Bowel cancer screening intentions
Time Frame
2 weeks post intervention
Title
Screening behaviour
Time Frame
2 weeks post intervention
Title
Self reported bowel cancer symptoms
Time Frame
2 weeks post intervention
Title
Evaluation of intervention materials
Time Frame
2 weeks post intervention
Title
Influence of doctor on screening decision
Time Frame
2 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten J McCaffery, PhD
Phone
+61 (0) 2 9351 7220
Email
kirstenm@health.usyd.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Sian K Smith, BSc (Hons)
Phone
+61 (0) 2 9351 7220
Email
sians@health.usyd.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McCaffery J Kirsten, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Valley Research Foundation
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2293
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten J McCaffery, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18494957
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.
Results Reference
background
PubMed Identifier
20978060
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.
Results Reference
derived

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

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