Self-compression Mammography in Clinical Practice

NCT04009278 | Completed

• 1 other identifier: RCT Pristina 2/TR
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammography; Breast Cancer

Keywords

Pain and discomfort

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Breast thickness at the time of exposure (cm)

  This outcome is measured at the baseline mammography.

• Maximum compression (daN)

  This outcome is measured at the baseline mammography.

• Pain during compression

  pain will be evaluated immediately after baseline mammography execution

• Memory of pain in previous mammography

  before the follow up mammography, i.e. approximately 1 year after baseline mammography

• Anxiety

  Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.

Study Arms (2)

1. Self-compression arm

EXPERIMENTAL

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

2. Control arm

NO INTERVENTION

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

Interventions

Self compression arm OTHER

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.

1. Self-compression arm

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Laura Canovi

Reggio Emilia, RE, 42123, Italy

Location

Related Publications (16)

• Miller D, Livingstone V, Herbison P. Interventions for relieving the pain and discomfort of screening mammography. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002942. doi: 10.1002/14651858.CD002942.pub2.

  PMID: 18254010 BACKGROUND

• Andrews FJ. Pain during mammography: implications for breast screening programmes. Australas Radiol. 2001 May;45(2):113-7. doi: 10.1046/j.1440-1673.2001.00889.x.

  PMID: 11380352 BACKGROUND

• Poulos A, McLean D, Rickard M, Heard R. Breast compression in mammography: how much is enough? Australas Radiol. 2003 Jun;47(2):121-6. doi: 10.1046/j.0004-8461.2003.01139.x.

  PMID: 12780439 BACKGROUND

• Mercer CE, Hogg P, Lawson R, Diffey J, Denton ER. Practitioner compression force variability in mammography: a preliminary study. Br J Radiol. 2013 Feb;86(1022):20110596. doi: 10.1259/bjr.20110596.

  PMID: 23385990 BACKGROUND

• Mendat CC, Mislan D, Hession-Kunz L. Patient comfort from the technologist perspective: factors to consider in mammographic imaging. Int J Womens Health. 2017 May 18;9:359-364. doi: 10.2147/IJWH.S129817. eCollection 2017.

  PMID: 28572739 BACKGROUND

• Davey B. Pain during mammography: possible risk factors and ways to alleviate pain. Radiography. 2007;13:5

  BACKGROUND

• de Groot JE, Branderhorst W, Grimbergen CA, den Heeten GJ, Broeders MJM. Towards personalized compression in mammography: a comparison study between pressure- and force-standardization. Eur J Radiol. 2015 Mar;84(3):384-391. doi: 10.1016/j.ejrad.2014.12.005. Epub 2014 Dec 13.

  PMID: 25554008 BACKGROUND

• Feder K, Grunert JH. Is Individualizing Breast Compression during Mammography useful? - Investigations of pain indications during mammography relating to compression force and surface area of the compressed breast. Rofo. 2017 Jan;189(1):39-48. doi: 10.1055/s-0042-119450. Epub 2016 Dec 21.

  PMID: 28002858 BACKGROUND

• Guidelines for Quality Assurance in Mammography Screening, third edition, The National Cancer Screening Service Board 2008

  BACKGROUND

• de Groot JE, Broeders MJ, Grimbergen CA, den Heeten GJ. Pain-preventing strategies in mammography: an observational study of simultaneously recorded pain and breast mechanics throughout the entire breast compression cycle. BMC Womens Health. 2015;15:26. doi: 10.1186/s12905-015-0185-2. Epub 2015 Mar 15.

  PMID: 25783657 BACKGROUND

• Van Goethem M, Mortelmans D, Bruyninckx E, Verslegers I, Biltjes I, Van Hove E, De Schepper A. Influence of the radiographer on the pain felt during mammography. Eur Radiol. 2003 Oct;13(10):2384-9. doi: 10.1007/s00330-002-1686-6. Epub 2002 Nov 14.

  PMID: 14534806 BACKGROUND

• Lau S, Abdul Aziz YF, Ng KH. Mammographic compression in Asian women. PLoS One. 2017 Apr 18;12(4):e0175781. doi: 10.1371/journal.pone.0175781. eCollection 2017.

  PMID: 28419125 BACKGROUND

• Taplin SH, Rutter CM, Finder C, Mandelson MT, Houn F, White E. Screening mammography: clinical image quality and the risk of interval breast cancer. AJR Am J Roentgenol. 2002 Apr;178(4):797-803. doi: 10.2214/ajr.178.4.1780797.

  PMID: 11906848 BACKGROUND

• Shrestha S, Poulos A, The effect of verbal information on the experience of discomfort in mammography, Radiography, Volume 7, Issue 4, Pages 271-277; 2001

  BACKGROUND

• Kornguth PJ, Keefe FJ, Wright KR, Delong DM. Mammography pain in women treated conservatively for breast cancer. J Pain. 2000 Winter;1(4):268-74. doi: 10.1054/jpai.2000.7884.

  PMID: 14622609 BACKGROUND

• 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.

  PMID: 35869315 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Canovi, RT

  Arcispedale S.Maria Nuova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each patient is identified in the study by a Subject Number (Subject No.), that is assigned when the patient is registered for mammography and is retained as the primary identifier for the patient throughout his/her entire participation in the trial. The allocation to experimental or control arm ill be open to patients and the research staff. The Image quality evaluations of Radiologists and the Radiographers are performed blindly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: July 5, 2019
• Study Start: January 25, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2020
• Last Updated: June 12, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)