SEINIOR:Quality of Life and Breast Cancer in Older Women

NCT04038606 | Unknown

• 1 other identifier: 2016-A00286-45
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• QLQ-C30 (Global Health Status)

  Baseline and 6 months

• Psychological profile

  Baseline and 6 months

Study Arms (2)

acceptance of mastectomy

ACTIVE COMPARATOR

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

rejection of mastectomy

EXPERIMENTAL

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

Interventions

Determination of acceptance and / or rejection of mastectomy OTHER

Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)

acceptance of mastectomy; rejection of mastectomy

Eligibility Criteria

• Age: 75 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under 75 years
• Male
• Patients under legal protection

Sponsors & Collaborators

• Central Hospital Saint Quentin: lead

Study Sites (1)

Centre Hospitalier de Saint-Quentin;

Saint-Quentin, Aisne, 02100, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ATTIER-ZMUDKA Dr Jadwiga, PI

  Saint Quentin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ATTIER-ZMUDKA Dr Jadwiga, IC

CONTACT

00333 23 06 72 16; J.ATTIER@ch-stquentin.fr

BOULANOUAR M Abdelkrim, CRA

CONTACT

0033323067861; AK.BOULANOUAR@ch-stquentin.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: July 31, 2019
• Study Start: December 15, 2016
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: July 31, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)