SEINIOR:Quality of Life and Breast Cancer in Older Women (SEINIOR)

Quality of Life and Breast Cancer in Older Women

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Determination of acceptance and / or rejection of mastectomy

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aisne
    • Saint-Quentin, Aisne, France, 02100
      • Recruiting
      • Centre Hospitalier de Saint-Quentin;
      • Contact: ATTIER Dr Jadwiga, PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acceptance of mastectomy; 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.	Other: Determination of acceptance and / or rejection of mastectomy; Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
Experimental: rejection of mastectomy; 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.	Other: Determination of acceptance and / or rejection of mastectomy; Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months	the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized monitoring and assessment of care outcomes in adult patients. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QLQ-C30 (Global Health Status)	Quality of life (QoL or QOL) is the perceived quality of an individual's daily life, that is, an assessment of their well-being or lack thereof. This includes all emotional, social and physical aspects of the individual's life;All of the scales and single-item measures range in score from 0 to 100.	Baseline and 6 months
Psychological profile	Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Central Hospital Saint Quentin
• Investigators: Principal Investigator: ATTIER-ZMUDKA Dr Jadwiga, PI, Saint Quentin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Anticipated): December 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: July 27, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-A00286-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Participants completed a questionnaire that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile.

Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No