Decision-aid on Breast Cancer Screening

Mario Negri Institute for Pharmacological Research

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Standard information; Other: Decision-aid

Study type: Interventional

Funder types: Other

Identifiers

NCT03097653

IRFMN-AIRC-6901

Details and patient eligibility

About

The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.

Full description

Breast cancer is the most common cancer in women. In Italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. Results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. Decision aids are an effective way to support lay people in their decisions about health.

Enrollment: 1,001 patients

Sex: Female

Ages: 45 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 45-69, according to the target age of the screening centres involved;
• New invited women in mammography screening programme.

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,001 participants in 2 patient groups

Decision-aid

Experimental group

Treatment:

Other: Decision-aid

Standard information

Active Comparator group

Treatment:

Other: Standard information