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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00765869




Registration number
NCT00765869
Ethics application status
Date submitted
1/10/2008
Date registered
3/10/2008
Date last updated
3/10/2008

Titles & IDs
Public title
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening
Scientific title
A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
Secondary ID [1] 0 0
ACTRN12608000011381
Secondary ID [2] 0 0
HREC10403
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Bowel cancer screening decision aid
Other interventions - Bowel cancer screening decision aid
Other interventions - Australian Government Bowel Cancer Screening booklet

Experimental: 1 - Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)

Experimental: 2 - Bowel cancer screening decision with DVD only

Active Comparator: 3 - Australian Government Bowel Cancer Screening consumer information booklet


Other interventions: 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)

Other interventions: 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)

Other interventions: 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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Informed choice
Timepoint [1] 0 0
2 weeks post intervention
Primary outcome [2] 0 0
Involvement in screening decision
Timepoint [2] 0 0
2 weeks post intervention
Secondary outcome [1] 0 0
Anxiety
Timepoint [1] 0 0
2 weeks post intervention
Secondary outcome [2] 0 0
Bowel cancer worry
Timepoint [2] 0 0
2 weeks post intervention
Secondary outcome [3] 0 0
Decisional conflict
Timepoint [3] 0 0
2 weeks post intervention
Secondary outcome [4] 0 0
Decision satisfaction
Timepoint [4] 0 0
2 weeks post intervention
Secondary outcome [5] 0 0
Bowel cancer screening interest
Timepoint [5] 0 0
2 weeks post intervention
Secondary outcome [6] 0 0
Bowel cancer screening intentions
Timepoint [6] 0 0
2 weeks post intervention
Secondary outcome [7] 0 0
Screening behaviour
Timepoint [7] 0 0
2 weeks post intervention
Secondary outcome [8] 0 0
Self reported bowel cancer symptoms
Timepoint [8] 0 0
2 weeks post intervention
Secondary outcome [9] 0 0
Evaluation of intervention materials
Timepoint [9] 0 0
2 weeks post intervention
Secondary outcome [10] 0 0
Influence of doctor on screening decision
Timepoint [10] 0 0
2 weeks post intervention

Eligibility
Key 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
Minimum age
55 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Hunter Valley Research Foundation - Newcastle
Recruitment postcode(s) [1] 0 0
2293 - Newcastle

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00765869
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
McCaffery J Kirsten, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten J McCaffery, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 2 9351 7220
Fax 0 0
Email 0 0
kirstenm@health.usyd.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00765869