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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038606
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital Saint Quentin

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


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Determination of acceptance and / or rejection of mastectomy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Quality of Life and Breast Cancer in Older Women
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


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.:-)




Primary Outcome Measures :
  1. Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months [ Time Frame: Baseline and 6 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 :
  1. QLQ-C30 (Global Health Status) [ Time Frame: Baseline and 6 months ]
    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.

  2. Psychological profile [ Time Frame: Baseline and 6 months ]
    Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038606


Contacts
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Contact: ATTIER-ZMUDKA Dr Jadwiga, IC 00333 23 06 72 16 J.ATTIER@ch-stquentin.fr
Contact: BOULANOUAR M Abdelkrim, CRA 0033323067861 AK.BOULANOUAR@ch-stquentin.fr

Locations
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France
Centre Hospitalier de Saint-Quentin; Recruiting
Saint-Quentin, Aisne, France, 02100
Contact: ATTIER Dr Jadwiga, PI         
Sponsors and Collaborators
Central Hospital Saint Quentin
Investigators
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Principal Investigator: ATTIER-ZMUDKA Dr Jadwiga, PI Saint Quentin Hospital
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Responsible Party: Central Hospital Saint Quentin
ClinicalTrials.gov Identifier: NCT04038606    
Other Study ID Numbers: 2016-A00286-45
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases