Projects and iniciatives Carlos III Health Institute

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Projects and iniciatives Carlos III Health Institute2019-06-10T14:04:31+00:00

Risk factors for adverse results during monitoring over two to five years for a prospective cohort of breast cancer patients CAMISS II multicentre study

Record no.: PI18/00674

Proyect:  

Risk factors for adverse results during monitoring over two to five years for a prospective cohort of breast cancer patients CAMISS II multicentre study

Project description: 

Objetive: 

1.- For patients with breast cancer, to independently identify the risk factors (and their respective categories) for the onset in the 2 to 5 years after the first treatment of the following adverse events: a) death; b) recurrence; c) re-admission; d) complications.

2.- To create predictive rules for each of the previous events/results (primarily death, recurrence, re-admission or complications), and to validate them with two different methodologies.

3.- To identify factors associated with inter-hospital variability and to detect problems of equity (based on age, gender, social class, country of birth, area of residence) with respect to treatments, diagnostic tests, monitoring and the availability of psycho-social support. Furthermore, analyse their relationship with the results obtained by the 5th year (in terms of death, recurrence, re-admission, complications and changes in the quality of life reported by the patient).

4.- To identify which factors are related to changes in quality of life in the 5th year after the intervention compared to the patient’s condition before any treatment and in the 2nd year. To create predictive rules based on changes in the quality of life in these patients.

5.- To identify and prioritise research needs from the point of view of patients and professionals, which have not yet been covered in previous studies but will be incorporated into the information to be collected during the monitoring of these patients.

Methodology:

Design: 

This is a prospective observational cohort study, to be conducted in 11 hospitals in four autonomous communities. It is based on a cohort that had already been set up with a Health Research Fund (FIS) project and another from the Department of Health of the Basque Government (CaMISS: Health Services Research into Breast Cancer). We propose monitoring these patients from the fifth year after the index treatment.

Scope:  

Participating hospitals: in the Basque Country, Galdakao-Usansolo Hospital, Cruces University Hospital, Basurto University Hospital, San Sebastian University Hospital, Onkologikoa and the Araba University Hospital; in Catalonia, Hospital del Mar; in Andalusia, Antequera Hospital and Costa del Sol Hospital; and in the Canary Islands, the Maternal Unit-Insular University Hospital of Gran Canaria and the Canaries University Hospital in Tenerife.

Data collection and analysis: 

A mixed methodology will be used, starting with a qualitative phase. Here patients and professionals will be consulted to identify the issues of greatest concern from their perspective, in order to incorporate them into the variables that will be collected later in the second phase. Consultations will be channelled through the Delphi consensus technique with three rounds, plus a nominal group at the end of the phase. In the second phase, quantitative data will be collected by reviewing the medical records and the questionnaires filled in by the patients, after signing the informed consent form.


Funding body:  

Carlos III Health Institute, European Regional Development Fund (ERDF)-”A way to make Europe”.

Amount Awarded: €53.240