Interest of Self-compression Technique on Tolerance of Mammography

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: mammography according to a standard procedure; Other: mammography according to an auto-compression procedure; Other: questionary

• Registration Number: NCT02866591
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	mammography according to a standard procedure	Patients have a mammography performed by the radiologist according to standard procedure.
Arm A	mammography according to an auto-compression procedure	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.
Arm B	questionary	Patients have a mammography performed by the radiologist according to standard procedure.
Arm A	questionary	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Centre François Baclesse; 🇫🇷 Caen, France

Institut Curie; 🇫🇷 Paris, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Cabinet de radiologie; 🇫🇷 Nancy, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-les-Nancy, France

Polyclinique Majorelle; 🇫🇷 Nancy, France