Clinical trial NCT02866591: Interest of Self-compression Technique on Tolerance of Mammography
Official title: Interest of Self-compression Technique on Tolerance of Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: mammography
pain
quality of life
screening
image quality
radiology
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography
timeFrame: 1 day
Secondary outcomes:
measure: Overall tolerance of mammography
timeFrame: 1 day
measure: Breast compression force
timeFrame: 1 day
measure: Thickness / compressing force ratio
timeFrame: 1 day
measure: Image quality
timeFrame: 1 day
measure: Overall assessment of the manipulator
timeFrame: 1 day
measure: Overall assessment of self-satisfaction of the patient at the end of the examination
timeFrame: 1 day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Nancy
country: France
facility: Cabinet de radiologie
city: Nancy
country: France
facility: Polyclinique Majorelle
city: Paris
country: France
facility: Institut Curie
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: HENROT Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.