PAMS - Multiple Morbidities for Elderly People with Breast Cancer
Head :
De Decker Laure, Unité d’Investigation clinique 19 – Gérontologie Clinique
Last update : 06/29/2014 | Version : 1 | ID : 8125
| General | |
| Identification | |
| Detailed name | Multiple Morbidities for Elderly People with Breast Cancer |
| Sign or acronym | PAMS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Demande CNIL en cours |
| General Aspects | |
| Medical area |
Cancer research Geriatrics |
| Health determinants |
Genetic |
| Others (details) | Breast cancer |
| Keywords | Comorbidity, oncological therapeutic toxicities, geriatrics |
| Scientific investigator(s) (Contact) | |
| Name of the director | De Decker |
| Surname | Laure |
| Address | Hôpital Laënnec – Médecine Aigue Gériatrique , Bd Monod, 44093 Nantes cedex 1 |
| Phone | +33 (0)2 40 08 48 08 |
| laure.dedecker@chu-nantes.fr | |
| Unit | Unité d’Investigation clinique 19 – Gérontologie Clinique |
| Organization | CHU de |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Recherche de financements en cours |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU de Nantes |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| 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. | In the absence of relevant literature data to support an effective calculation based on a numerical statistical hypothesis, no proposal for calculating minimum sample size. The size of the cohort was determined based on inclusion capacity during the last two years and monitoring by medical teams. 800 women are included. This number ensures a feasible study and the collection of maximum quality data. |
| Database objective | |
| Main objective | The main objective of the PAM study is to develop a prognostic score at 5-year survival for patients older than 65 years who have breast cancer. This score is calculated from breast cancer variables, medical, psychological and social characteristics, burden of morbidity, frailty and quality of life. Secondary objectives of the PAMS study are: - To investigate the influence of individually analysed geriatric parameters on choice of oncology treatment at 3 months. - To investigate the influence of quality of life on survival and the onset of toxicity at 3 months, 1 year and 5 years. To investigate the change in quality of life for patients at 3 months (immediately post-treatment), at 1 year (during chronic treatment and follow-up) and at 5 years. - To study changes in perception (Response Shift) over time through quality of life questionnaires, so as to distinguish between what is a change in perception and what is a change in quality of life when analysing changes in quality of life scores - To study the links between changes in perception over time through quality of life questionnaires and scores from Impact of Cancer questionnaires (IOC). - To evaluate the change in physical performance and autonomy in patients at 3 months, 12 months and 5 years. - To investigate the validity of the Lee Survival Score in this population at 5 years. - To investigate the geriatric and oncological parameters associated with sought medical healthcare, defined by unscheduled hospitalisation in the year following enrolment, at 3 months, 1 year and 5 years. - To assess the association between self-administered health questionnaires and geriatric evaluation parameters for this population. - To determine associations between prognostic score, onset of toxicity and oncology therapy at 5 years. - To determine associations between geriatric parameters, onset of toxicity and oncology therapy at 5 years. - To determine the most efficient comorbidity scale for estimating the tolerance to treatment offered to elderly people with breast cancer by stratifying tumour type and initial grade, as well as choice of treatment at 1 year. |
| Inclusion criteria | - Individuals over 65 years of age - Individuals diagnosed with breast cancer by anatomopathological confirmation - Individuals that have given written informed consent to participate in the study or informed consent by the person legally responsible. - Subjects covered by a social security scheme. - Subjects monitored by a cancer treatment centre or oncology service participating in the study. |
| Population type | |
| Age |
Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
Regional |
| French regions covered by the database |
Pays de la Loire |
| Detail of the geography area | - Patient enrolment will be carried out in two cancer treatment centres (the René Gauducheau Centre in Nantes and the Paul Papin Centre in Angers), and two university hospitals (Angers and Nantes). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2014 |
| Date of last collection (YYYY or MM/YYYY) | 2021 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 800 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Biological data (detail) | Presence of hormone receptors, HER2 (membrane protein), SBR (Scarff Bloom and Richardson), and genomic criteria. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Others |
| Details of biobank content | -- |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | An e-CRF will be designed by a data manager in accordance with protocol |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 5 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
