Interest of Self-compression Technique on Tolerance of Mammography (ITACTs)

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: mammography according to an auto-compression procedure; Other: questionary; Other: mammography according to a standard procedure

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Nancy, France, 54000
    • Cabinet de Radiologie
  • Nancy, France, 54000
    • Polyclinique Majorelle
  • Paris, France, 75248
    • Institut Curie
  • Vandoeuvre-les-Nancy, France, 54519
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Adult patients ≥ 18 years and ≤ 75 years of age
• ECOG performance <2
• Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
• Ability to provide written informed consent
• Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion Criteria:

• Eastern Cooperative Oncology Group performance status ≥ 2
• Treatment for benign lesion with surgery for less than 3 years
• Treatment for cancer with surgery and / or radiotherapy for less than 3 years
• Biopsy for less than 1 year
• Breast prosthesis
• Mastectomy
• Assessment motivated by a clinical breast abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Patients have a mammography performed by themselves according to auto-compression procedure. The radiologist leads the compression at a minimum threshold of 40 Newton, then leaves the control of the compression to the patient. The radiologist treats only the positioning of the breast on the sensor.	Other: mammography according to an auto-compression procedure; Other: questionary
Active Comparator: Arm B; Patients have a mammography performed by the radiologist according to standard procedure.	Other: questionary; Other: mammography according to a standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography	The comparison will be evaluated by the thickness (mm) of breast compressed	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall tolerance of mammography	The overall tolerance of mammography will be assessed by the patient after 4 shots. The pain felt by the patient will be assessed using a visual analog scale.	1 day
Breast compression force	Value measured on compressive force console (Newtons)	1 day
Thickness / compressing force ratio		1 day
Image quality	The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale	1 day
Overall assessment of the manipulator	The appreciation of the manipulator will be assessed using a 4-point scale	1 day
Overall assessment of self-satisfaction of the patient at the end of the examination	The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)	1 day

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: HENROT Philippe, MD, Institut de Cancérologie de Lorraine

Publications and helpful links

General Publications

• Henrot P, Boisserie-Lacroix M, Boute V, Troufleau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: pain; quality of life; screening; image quality; mammography; radiology
• Other Study ID Numbers: 2012-A00248-35

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No