Self-compression Mammography in Clinical Practice

Not Applicable

Completed

• Conditions: Mammography; Breast Cancer
• Interventions: Other: Self compression arm

• Registration Number: NCT04009278
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-25
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Primary Completion: 2019-07-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 502

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Self-compression arm	Self compression arm	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.

Primary Outcome Measures

Name	Time	Method
Image quality: radiographers' scale.	This outcome is measured at the baseline mammography.	Radiographers evaluate the image quality after exam with a radiographer specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.
Image quality: radiologists' scale.	This outcome is measured at the baseline mammography.	Radiologists evaluate the image quality after exam a radiologist specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.
Average glandular dose administered (mSv)	This outcome is measured at the baseline mammography.	Average glandular dose administered during mammography is automatically computed by the machine according to an algorithm using the data on the quantity of radiation emitted and the radiation captured by the detector.

Secondary Outcome Measures

Name	Time	Method
Discomfort	Discomfort will be measured just after the baseline mammography.	Discomfort will be measured with a one-item scale with five-point range (no, slight, moderate, considerable and severe discomfort).
Memory of pain in previous mammography	before the follow up mammography, i.e. approximately 1 year after baseline mammography	visual assessment scale
Breast thickness at the time of exposure (cm)	This outcome is measured at the baseline mammography.	Breast thickness is measured automatically by the machine. This endpoint will be evaluated using single exposure as statistical unit, taking into account the autocorrelation of the 4 exposures in the same woman.
Pain during compression	pain will be evaluated immediately after baseline mammography execution	visual assessment scale
Execution time of the exam:	This outcome is measured at the baseline mammography.	We evaluate: - total time (from randomization to close examination). Times are automatically registered by the radiology information system.; - Second breast time (from the acquisition of the second right breast projection to the acquisition of the second left breast projection)
Anxiety	Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.	questionnaire: State Trait Anxiety Inventory for adults - form Y (D. Spielberger).; The scale has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.
Maximum compression (daN)	This outcome is measured at the baseline mammography.	Compression is measured automatically by the machine. This endpoint will be evaluated using single exposure as statistical unit, taking into account the autocorrelation of the 4 exposures in the same woman.
Participation in follow up mammography	1 year (+/- 2 months) after baseline mammography	Number of women presenting to follow up mammography (1 year +/-2 months)/number of recruited women referred to follow up mammography after 1 year

Trial Locations

Locations (1)

Laura Canovi; 🇮🇹 Reggio Emilia, RE, Italy