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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Mammography
• Intervention / Treatment: Other: Self compression arm

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RE
    • Reggio Emilia, RE, Italy, 42123
      • Laura Canovi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1. 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.	Other: Self compression arm; 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.
NO_INTERVENTION: 2. Control arm; The mammography will be performed as normal clinical practice, with compression controlled by the radiographer.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: Laura Canovi, RT, Arcispedale S.Maria Nuova

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Davey B. Pain during mammography: possible risk factors and ways to alleviate pain. Radiography. 2007;13:5
• 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.
• 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.
• Guidelines for Quality Assurance in Mammography Screening, third edition, The National Cancer Screening Service Board 2008
• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pain and discomfort
• Other Study ID Numbers: RCT Pristina 2/TR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The differences in average glandular dose between the two groups will be compared with a student test if the distributions can be assimilated to a normal one and with non-parametric test in case of non-normality of the distributions.

If the average glandular dose is not lower in the study group (superiority test) and / or the proportion of women with suboptimal compression (<10daN) and> = in the experimental group, the image quality measured with a qualitative subjective scale of the radiologist with a non-parametric test (superiority test).

For secondary endpoints, the results will be compared between the two arms with student tests for the medium with normal distribution, non-parametric tests for non-normal distributions, while for the proportions a chi-square test will be performed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No