Living Conditions and Breast Cancer

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT01626950

2012-A00377-36 (Other Identifier)

AO/INCA/2011/JPD

Details and patient eligibility

About

The main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).

Full description

Our secondary objectives include:

• To study the link between cancer stage at diagnosis and diverse parameters describing living conditions
• To construct a new score for social fragility based on new data collected in this study, and to compare this score with the EPICES score
• To study patient quality of life at study baseline

Enrollment: 684 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (for cases):

• Patient has been correctly informed about the study, and agrees to participate
• The patient must be insured or beneficiary of a health insurance plan
• Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage III-IV, surgical cases

Inclusion Criteria (for controls):

• Patient has been correctly informed about the study, and agrees to participate
• The patient must be insured or beneficiary of a health insurance plan
• Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage I-II, surgical cases

Exclusion Criteria (for cases and controls):

• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient is pregnant, parturient, or breastfeeding
• The patient is opposed to study participation
• Women not able to answer a questionnaire due to language barriers or due to vascular or degenerative cerebral dysfunction
• It is impossible to correctly inform the patient

Trial design

684 participants in 2 patient groups

Cases - Stage III-IV breast cancer

Description:

The women in this group have been diagnosed with stage III-IV incident cancer.

Controls: Stage I-II breast cancer

Description:

The women in this group have been diagnosed with stage I-II incident cancer.