Self-compression Mammography in Clinical Practice

Study Overview
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Brief Summary
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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.

Official Title
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Self-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography

Conditions
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Mammography, Breast Cancer

Intervention / Treatment
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* Other: Self compression arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be proposed to women presenting for a clinical mammography . Randomization will be determined by the machine's order entry system. All women will have a mammogram performed on the Pristina. In the control arm, mammography will be performed as normal clinical practice, with compression controlled by the radiographer. In the experimental arm the radiographer will first explain 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Self-compression arm<br>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. | Other: Self compression arm<br>* The optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode.<br>|
| No Intervention: 2. Control arm<br>The mammography will be performed as normal clinical practice, with compression controlled by the radiographer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average glandular dose administered (mSv) | 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. | This outcome is measured at the baseline mammography. | 
| Image quality: radiographers' scale. | 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. | This outcome is measured at the baseline mammography. | 
| Image quality: radiologists' scale. | 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. | This outcome is measured at the baseline mammography. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast thickness at the time of exposure (cm) | 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. | This outcome is measured at the baseline mammography. | 
| Maximum compression (daN) | 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. | This outcome is measured at the baseline mammography. | 
| Pain during compression | visual assessment scale | pain will be evaluated immediately after baseline mammography execution | 
| Memory of pain in previous mammography | visual assessment scale | before the follow up mammography, i.e. approximately 1 year after baseline mammography | 
| Anxiety | 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. | Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography. | 
| Discomfort | Discomfort will be measured with a one-item scale with five-point range (no, slight, moderate, considerable and severe discomfort). | Discomfort will be measured just after the baseline mammography. | 
| Execution time of the exam: | 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) | This outcome is measured at the baseline mammography. | 
| Participation in follow up 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 | 1 year (+/- 2 months) after baseline mammography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain and discomfort