Interest of Self-compression Technique on Tolerance of Mammography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

mammography according to an auto-compression procedure

Intervention Type OTHER

questionary

Intervention Type OTHER

Arm B

Patients have a mammography performed by the radiologist according to standard procedure.

Group Type ACTIVE_COMPARATOR

mammography according to a standard procedure

Intervention Type OTHER

questionary

Intervention Type OTHER

Interventions

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mammography according to an auto-compression procedure

Intervention Type OTHER

mammography according to a standard procedure

Intervention Type OTHER

questionary

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No