MedDataX Logo

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

NCT ID: NCT00765869

Last Updated: 2008-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Decision support techniques

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Bowel cancer screening decision aid

Intervention Type OTHER

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)

2

Bowel cancer screening decision with DVD only

Group Type EXPERIMENTAL

Bowel cancer screening decision aid

Intervention Type OTHER

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)

3

Australian Government Bowel Cancer Screening consumer information booklet

Group Type ACTIVE_COMPARATOR

Australian Government Bowel Cancer Screening booklet

Intervention Type OTHER

A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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)

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Screening and Test Evaluation program,University of Sydney

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

McCaffery J Kirsten, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hunter Valley Research Foundation

Newcastle, New South Wales, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kirsten J McCaffery, PhD

Role: CONTACT

Phone: +61 (0) 2 9351 7220

Email: [email protected]

Sian K Smith, BSc (Hons)

Role: CONTACT

Phone: +61 (0) 2 9351 7220

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18494957 (View on PubMed)

Stacey D, Lewis KB, Smith M, Carley M, Volk R, Douglas EE, Pacheco-Brousseau L, Finderup J, Gunderson J, Barry MJ, Bennett CL, Bravo P, Steffensen K, Gogovor A, Graham ID, Kelly SE, Legare F, Sondergaard H, Thomson R, Trenaman L, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2024 Jan 29;1(1):CD001431. doi: 10.1002/14651858.CD001431.pub6.

Reference Type DERIVED
PMID: 38284415 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20978060 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACTRN12608000011381

Identifier Type: -

Identifier Source: secondary_id

HREC10403

Identifier Type: -

Identifier Source: org_study_id