ITMO public health
Last update : 07/22/2015 | Version : 3 | ID : 60040
| General | |
| Identification | |
| Detailed name | Longitudinal study of the psychosocial impact of breast pathology |
| Sign or acronym | ELIPPSE 40 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Social and psychosocial factors |
| Keywords | relapse, life after acute episode of illness, Health episodes, death, side effects |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rey |
| Surname | Dominique |
| Phone | +33 (0)4 96 10 28 76 |
| dominique.rey@inserm.fr | |
| Unit | U912 |
| Organization | INSERM |
| Name of the director | Moatti |
| Surname | Jean-Paul |
| jean-paul.moatti@ird.fr | |
| Organization | IRD |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Région PACA, INCa, Cancéropôle, FDF, Action concertée Incitative (ACI) du Ministère de la Recherche, DGS, Association pour la Recherche sur le Cancer (ARC). |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Other bodies active in creating this cohort: CMNSS, CRAM-DRSM, RSI Sample 1: all women enrolled had a valid medical questionnaire, had completed the questionnaire at 28 months and who were working at the time of diagnosis (266 women). Sample 2: all women with a valid medical questionnaire and who responded to follow-up questionnaires at 28 months (331 women). Sample 3: face-to-face interview with 21 women concerning the development of their professional situation following a minimum of 16 months after breast cancer diagnosis Closing date for inclusion:01/01/2010 |
| Database objective | |
| Main objective | General objective: to study - long-term quality of life and follow-up (5 to 10 years) of breast cancer survivors below the age of 40 (18 to 40 years old) within the Provence-Alpes-Côte d'Azur (PACA) region. - the impact of cancer and treatment on reproduction - children's experiences - return to work, access to first-time employment - body image - adherence to treatment, in particular hormonal therapy - access to loans and insurance. |
| Inclusion criteria | Women between 18 and 40 years old who have been diagnosed with a long-duration disease (LDD) for breast cancer confirmed by biopsy between July 2005 and July 2011, and living in either the PACA region or Corsica. Women with distant metastasis at diagnosis or severe psychiatric disorders were excluded, as well as those who were unable to complete the telephone questionnaire. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
Regional |
| French regions covered by the database |
Corse Provence - Alpes - Côte d'Azur |
| Detail of the geography area | PACA Region and Corsica |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2005 |
| Date of last collection (YYYY or MM/YYYY) | 01/2015 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 377 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: from paper questionnaire (manual input) Interview: direct input Clinical Examinations: handwritten (manual input) Interviews by telephone using CATI (computer-assisted collection) method |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 5 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CRAM |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-ELIPPSE-40 |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams, access according to questionnaires and databases, access for other teams may only be possible upon completion of studies and following our own data mining, except when directly collaborating on specific topics. Data may be used by industrial teams Access according to industry collaboration will be timely considered based on specific studies without structural support |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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