Self-compression Mammography in Clinical Practice

Breast Cancer Clinical Trial

— Pristina2/TR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009278
• Other study ID #: RCT Pristina 2/TR
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Mammography

Intervention

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.

Locations

Country	Name	City	State
Italy	Laura Canovi	Reggio Emilia	RE

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (15)

Andrews FJ. Pain during mammography: implications for breast screening programmes. Australas Radiol. 2001 May;45(2):113-7. — View Citation

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.2014.12.00 — View Citation

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. d — View Citation

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: 10.105 — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Poulos A, McLean D, Rickard M, Heard R. Breast compression in mammography: how much is enough? Australas Radiol. 2003 Jun;47(2):121-6. — View Citation

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

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. — View Citation

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. Epub 2002 Nov 14. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Pain during compression	visual assessment scale	pain will be evaluated immediately after baseline mammography execution
Secondary	Memory of pain in previous mammography	visual assessment scale	before the follow up mammography, i.e. approximately 1 year after baseline mammography
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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