Living Conditions and Breast Cancer
N/A
N/A
Female
Breast Neoplasms
Trial Information
Living Conditions and Breast Cancer
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
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Cross-Sectional
Outcome Measure:
The odds ratio for having a stage I-II diagnosis versus a stage III-IV diagnosis according to EPICE score category (social fragility versus no social fragility).
Outcome Description:
The main criterion is the estimation 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).
Outcome Time Frame:
Baseline (Day 0; cross-sectional study)
Safety Issue:
No
Principal Investigator
Jean Pierre Daurès, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Hospitalier Universitaire de Nîmes
Authority:
France: Committee for the Protection of Personnes
Study ID:
AO/INCA/2011/JPD
NCT ID:
NCT01626950
Start Date:
June 2012
Completion Date:
June 2014
Related Keywords:
- Breast Neoplasms
- Breast cancer
- living conditions
- social fragility
- Breast Neoplasms
- Neoplasms
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