Self-compression Mammography in Clinical Practice (Pristina2/TR)

Azienda USL Reggio Emilia - IRCCS

Status: Completed

Conditions: Breast Cancer; Mammography

Treatments: Other: Self compression arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04009278

RCT Pristina 2/TR

Details and patient eligibility

About

Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this allows to reduce the thickness of the breast thus improving the quality of the diagnostic image and reducing the dose of radiation necessary to obtain a clear image. Many women perceive as painful this compression, including women who have been treated for breast cancer.

Pain can discourage asymptomatic women to present themselves periodically to screening mammography, while an increasing number of women in follow-up after conservative surgery have to withstand the pain caused by mammography.

Some studies mention various factors that are responsible for pain when performing mammography: breast sensitivity, anxiety level, expected pain and staff attitude. Some studies have also identified breast density, breast volume and menstrual phase as other influencing factors, although not all studies support these hypothesis. The technical characteristics of the equipment can greatly affect annoyance, sense of oppression, pain. The technological proposals to reduce the discomfort of the patients concern various items: flexible compressors, self-compression devices under the supervision of the technician who performs the positioning and the minimum initial compression, environmental factors such as equipment noise reduction, chromatic, sound and sensory effects (eg: aromatic diffusers).

The aim of our study is to evaluate the effectiveness of the self-compression compared to the standard one, in reducing annoyance, a sense of oppression and pain, and to evaluate the difference of the average glandular dose given to the woman for each projection.

Self-compression may help reaching better compression tolerating the discomfort and pain induced thus allowing to achieve a lower thickness, a lower glandular dose and a better image.

Enrollment: 502 patients

Sex: Female

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women in follow-up after surgery
• Symptomatic women undergoing mammography
• Early diagnosis in asymptomatic women outside the organized screening program (these women are predominantly aged 40-44 / 75-85)
• Women with familiar risk

Exclusion criteria

• Augmentation prostheses
• Women in screening with active invitation
• Physical impossibility to use the self-compression command
• Inability to provide consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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502 participants in 2 patient groups

1. Self-compression arm

Experimental group

Description:

Intervention consist in a explanation by the radiographer to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain.

Treatment:

Other: Self compression arm

2. Control arm

No Intervention group

Description:

The mammography will be performed as normal clinical practice, with compression controlled by the radiographer.