NCT00247442

Brief Summary

The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
670

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 28, 2006

Status Verified

June 1, 2005

First QC Date

October 30, 2005

Last Update Submit

September 27, 2006

Conditions

Breast Neoplasms

Keywords

Mammography screeningBreast cancer screeningScreening outcomesDecision aidDecision support toolInformed choice

Outcome Measures

Primary Outcomes (2)

  • Informed choice

  • Participation

Secondary Outcomes (3)

  • Decisional conflict

  • Knowledge

  • Anxiety

Interventions

Decision aidBEHAVIORAL

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women who are due their FIRST screening mammogram over the age of 70, and who have previously participated in screening mammography at BreastScreen NSW.

You may not qualify if:

  • Inability to complete a telephone interview in English.
  • Personal history of breast cancer (invasive and pre-invasive).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

Related Publications (1)

  • Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.

    PMID: 38726892DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Heather Davey, B.Psych, MPH

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Nehmat Houssami, MBBS, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Erin Mathieu, B.Ed, MPH

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Andrew Page, BA (Hons)

    BreastScreen NSW

    PRINCIPAL INVESTIGATOR

  • Richard Taylor, MBBS, PhD

    BreastScreen NSW

    PRINCIPAL INVESTIGATOR

  • Sian Smith, BSc (Hons)

    University of Sydney

    PRINCIPAL INVESTIGATOR

  • Phyllis Butow, MPH, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2005

First Posted

November 1, 2005

Study Start

January 1, 2006

Study Completion

April 1, 2006

Last Updated

September 28, 2006

Record last verified: 2005-06

Locations

AU(1)