Interest of Self-compression Technique on Tolerance of Mammography

Study Overview
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Brief Summary
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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.

Official Title
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Interest of Self-compression Technique on Tolerance of Mammography

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: mammography according to an auto-compression procedure
* Other: mammography according to a standard procedure
* Other: questionary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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<br> <br> Other: questionary<br> <br> |
| Active Comparator: Arm B<br>Patients have a mammography performed by the radiologist according to standard procedure. | Other: mammography according to a standard procedure<br> <br> Other: questionary<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mammography, pain, quality of life, screening, image quality, radiology