Clinical trial NCT00247442: Australian Screening Mammography Decision Aid Trial (ASMDAT)
Official title: An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Mammography screening
Breast cancer screening
Screening outcomes
Decision aid
Decision support tool
Informed choice
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 670
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

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.

Detailed description: The primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older.

There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.

Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.

The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Informed choice
measure: Participation
Secondary outcomes:
measure: Decisional conflict
measure: Knowledge
measure: Anxiety
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Heather Davey, B.Psych, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Nehmat Houssami, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Erin Mathieu, B.Ed, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: BreastScreen NSW
name: Andrew Page, BA (Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: BreastScreen NSW
name: Richard Taylor, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Sian Smith, BSc (Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Phyllis Butow, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: