Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2009
Actual
Sample size
Target
555
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/ct2/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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00765869