SEINIOR:Quality of Life and Breast Cancer in Older Women

Central Hospital Saint Quentin

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: Determination of acceptance and / or rejection of mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04038606

2016-A00286-45

Details and patient eligibility

About

Background :

Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.

Purpose :

The purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:

• Assess the determinants of acceptance and / or rejection of mastectomy based on personal background (level of fragility, self-image) and linked to cancer
• Assess the quality of life, 6 months later, of women who underwent or not mastectomy, and appreciate the determinants

Abstract :

The total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.

The research hypothesis is that the acceptability of mastectomy is not good in elderly women

Full description

Primary outcome:

Better detection of comorbidity and geriatric syndromes in vulnerable patients Better detection of a degradation of the quality of life at D0 (at diagnosis)

Secondary outcomes:

Better support for quality of life and psychological support after mastectomy (revaluation to 6 months) Integration of patients in the geriatric sector and implementation of regular monitoring Study design: prospective, multicenter

Enrollment: 174 estimated patients

Sex: Female

Ages: 75 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Elderly patients about or over 75 years
2. Female
3. Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed
4. Ability to understand and give freely consent
5. Informed consent signed
6. Patient affiliated to the social security or entitled

Exclusion criteria

1. Patients under 75 years
2. Male
3. Patients under legal protection

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

acceptance of mastectomy

Active Comparator group

Description:

Assess the determinants of acceptance of mastectomy based on personal background,Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory.

Treatment:

Other: Determination of acceptance and / or rejection of mastectomy

rejection of mastectomy

Experimental group

Description:

Assess the determinants of rejection of mastectomy based on personal background, Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory.

Treatment:

Other: Determination of acceptance and / or rejection of mastectomy