Communicating the benefits and harms of breast cancer screening: a randomised controlled trial evaluating an information booklet designed to help women approaching age 50 to make an informed decision about screening

Informed choice in mammography screening for breast cancer: comparing effects of breast screening information booklets with and without information on overdiagnosis among women approaching and entering the target age range for screening

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001035718

Enrollment

1061

Registered

2013-09-17

Start date

2014-01-06

Completion date

2014-07-14

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to evaluate a newly developed information booklet for women about breast cancer screening. Who is it for? People may be eligible to join this study if they are women aged 48-50 years residing in NSW. Women will not be eligible if they have a personal or strong family history of breast cancer, or if they have undergone any mammogram in the past 2 years. Potentially eligible participants will be randomly selected from the electoral roll and contacted by researchers. Study details Women in this study will be randomly (by chance) allocated to receive one of two different versions of a booklet. The booklets aim to provide clear and useful information about the benefits and harms of breast cancer screening, in order to enable women to make an informed decision about screening. The researchers will look at how women understand and interpret the information, as well as how it affects their screening attitudes, decisions, and experiences.

Interventions

The trial intervention is a purpose-designed screening information booklet containing information on breast screening benefits and harms over 20 years of participation, including evidence-based quantitative estimates of breast cancer mortality benefit, false positives, and overdiagnosis. Overdiagnosis – also called overdetection – means finding a breast cancer through screening that would otherwise never cause any symptoms or health problems for the woman during her life.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

48 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Female; aged 48-50 years; residing in NSW; fluent in spoken and written English

Exclusion criteria

Personal history of breast cancer; any mammogram in past 2 years; strong family history of breast cancer; having been advised of being at very high risk for breast cancer; having been advised of being likely to have a breast cancer gene mutation

Outcome results