Clinical trial NCT04009278: Self-compression Mammography in Clinical Practice
Official title: Self-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammography
Breast Cancer
Keywords: Pain and discomfort
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2019-07-05
Enrollment: 502
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average glandular dose administered (mSv)
timeFrame: This outcome is measured at the baseline mammography.
measure: Image quality: radiographers' scale.
timeFrame: This outcome is measured at the baseline mammography.
measure: Image quality: radiologists' scale.
timeFrame: This outcome is measured at the baseline mammography.
Secondary outcomes:
measure: Breast thickness at the time of exposure (cm)
timeFrame: This outcome is measured at the baseline mammography.
measure: Maximum compression (daN)
timeFrame: This outcome is measured at the baseline mammography.
measure: Pain during compression
timeFrame: pain will be evaluated immediately after baseline mammography execution
measure: Memory of pain in previous mammography
timeFrame: before the follow up mammography, i.e. approximately 1 year after baseline mammography
measure: Anxiety
timeFrame: Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.
measure: Discomfort
timeFrame: Discomfort will be measured just after the baseline mammography.
measure: Execution time of the exam:
timeFrame: This outcome is measured at the baseline mammography.
measure: Participation in follow up mammography
timeFrame: 1 year (+/- 2 months) after baseline mammography
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Laura Canovi
state: RE
Study officials:
affiliation: Arcispedale S.Maria Nuova
name: Laura Canovi, RT
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Iotti V, Giorgi Rossi P, Canovi L, Guberti M, Nitrosi A, Lippolis DG, Marchesi V, Besutti G, Ottone M, Vacondio R, Pattacini P; Self-Compression Reggio Emilia Working Group. Patient-centred care with self-compression mammography in clinical practice: a randomized trial compared to standard compression. Eur Radiol. 2023 Jan;33(1):450-460. doi: 10.1007/s00330-022-09002-z. Epub 2022 Jul 22.