NCT00765869

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
555

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

October 3, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

October 1, 2008

Last Update Submit

October 2, 2008

Conditions

Colorectal Neoplasms

Keywords

Decision support techniques

Outcome Measures

Primary Outcomes (2)

  • Informed choice

    2 weeks post intervention

  • Involvement in screening decision

    2 weeks post intervention

Secondary Outcomes (10)

  • Anxiety

    2 weeks post intervention

  • Bowel cancer worry

    2 weeks post intervention

  • Decisional conflict

    2 weeks post intervention

  • Decision satisfaction

    2 weeks post intervention

  • Bowel cancer screening interest

    2 weeks post intervention

  • +5 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

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

Other: Bowel cancer screening decision aid

2

EXPERIMENTAL

Bowel cancer screening decision with DVD only

Other: Bowel cancer screening decision aid

3

ACTIVE COMPARATOR

Australian Government Bowel Cancer Screening consumer information booklet

Other: Australian Government Bowel Cancer Screening booklet

Interventions

Bowel cancer screening decision aidOTHER

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)

1
Australian Government Bowel Cancer Screening bookletOTHER

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

3

Eligibility Criteria

Age55 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 55-64 years
  • Lower levels of education
  • English as a main language spoken at home
  • Average risk of bowel cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Valley Research Foundation

Newcastle, New South Wales, 2293, Australia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18494957BACKGROUND

  • 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.

    PMID: 38284415DERIVED

  • 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.

    PMID: 20978060DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • McCaffery J Kirsten, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten J McCaffery, PhD

CONTACT

+61 (0) 2 9351 7220kirstenm@health.usyd.edu.au

Sian K Smith, BSc (Hons)

CONTACT

+61 (0) 2 9351 7220sians@health.usyd.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 3, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

October 3, 2008

Record last verified: 2008-10

Locations

AU(1)