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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of acceptance and / or rejection of mastectomy
Sponsored by
Central Hospital Saint Quentin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

75 Years - 100 Years (Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Hospitalier de Saint-Quentin;Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

acceptance of mastectomy

rejection of mastectomy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Psychological profile
Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .

Full Information

First Posted
September 28, 2016
Last Updated
July 27, 2019
Sponsor
Central Hospital Saint Quentin
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1. Study Identification

Unique Protocol Identification Number
NCT04038606
Brief Title
SEINIOR:Quality of Life and Breast Cancer in Older Women
Acronym
SEINIOR
Official Title
Quality of Life and Breast Cancer in Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
December 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital Saint Quentin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants completed a questionnaires 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acceptance of mastectomy
Arm Type
Active Comparator
Arm 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.
Arm Title
rejection of mastectomy
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Determination of acceptance and / or rejection of mastectomy
Intervention Description
Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
Primary Outcome Measure Information:
Title
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
Description
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
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
QLQ-C30 (Global Health Status)
Description
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.
Time Frame
Baseline and 6 months
Title
Psychological profile
Description
Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly patients about or over 75 years Female Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed Ability to understand and give freely consent Informed consent signed Patient affiliated to the social security or entitled Exclusion Criteria: Patients under 75 years Male Patients under legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ATTIER-ZMUDKA Dr Jadwiga, IC
Phone
00333 23 06 72 16
Email
J.ATTIER@ch-stquentin.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BOULANOUAR M Abdelkrim, CRA
Phone
0033323067861
Email
AK.BOULANOUAR@ch-stquentin.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATTIER-ZMUDKA Dr Jadwiga, PI
Organizational Affiliation
Saint Quentin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Saint-Quentin;
City
Saint-Quentin
State/Province
Aisne
ZIP/Postal Code
02100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ATTIER Dr Jadwiga, PI

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

SEINIOR:Quality of Life and Breast Cancer in Older Women

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