Interest of Self-compression Technique on Tolerance of Mammography

Institut de Cancérologie de Lorraine550 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

550

Conditions

Breast Cancer

Interventions

mammography according to an auto-compression procedureOTHER

mammography according to a standard procedureOTHER

questionaryOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (6)

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Cabinet de radiologie

Nancy, France

Polyclinique Majorelle

Nancy, France

Outcomes

Primary Outcomes

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

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 1 day

Breast compression force

Value measured on compressive force console (Newtons)

Time frame: 1 day

Thickness / compressing force ratio

Time frame: 1 day

Image quality

The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale

Time frame: 1 day

Overall assessment of the manipulator

The appreciation of the manipulator will be assessed using a 4-point scale

Time frame: 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)

Time frame: 1 day

Data from ClinicalTrials.gov

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