Breast Cancer
Conditions
Keywords
mammography, pain, quality of life, screening, image quality, radiology
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.
Interventions
OTHERmammography according to an auto-compression procedure
OTHERmammography according to a standard procedure
OTHERquestionary
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Breast compression force | 1 day | Value measured on compressive force console (Newtons) |
| 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. |
| Overall assessment of the manipulator | 1 day | The appreciation of the manipulator will be assessed using a 4-point scale |
| 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) |
| Image quality | 1 day | The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale |
Countries
France
Outcome results
None listed