Australian Screening Mammography Decision Aid Trial: A De... | NCT00139048

Studies
Australian Screening Mammography Decision Aid Trial: A Decision Aid for Women Aged 40 Thinking About Starting Mammography Screening

NCT00139048

Sponsor

University of Sydney

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

200

Phase

Not Applicable

Conditions

Knowledge of Mammography Screening

Interventions

Decision Aid

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Aug 28, 2005

First Submission Date that Met QC Criteria

Aug 28, 2005

First Posted Date

Aug 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 5, 2017Actual

Description Module

Brief Summary

Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. The Decision Aid group will first read the decision aid, and then will be asked some demographic and knowledge questions. The control group will be asked the demographic and knowledge questions only. The control group will have access to the Decision Aid after they have completed the questions

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Decision Aid	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid.

Secondary Outcomes

Measure	Description	Time Frame
elicit womens views on the decision aid including ease of use, content and presentation of information,
assess the differences in intention to screen
assess the impact of the decision aid on informed choice

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female
aged between 38-45
have access to the internet

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alex Barratt	Screening and Test evaluation programme, School of Public Health, University of Sydney	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sydney		Camperdown	New South Wales	2006	Australia

Intervention Browse Module

MeSH Terms

ID	Term
D003661	Decision Support Techniques

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided