Oncology
Conditions
Keywords
Oncological Network, Multidisciplinary Oncology Groups
Brief summary
The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.
Detailed description
The ROC platform therefore represents a multicenter database and a growing source of data and information regarding cancer patients in the Campania region. The need for multicenter databases is supported by the results obtained with both retrospective and prospective studies. Many retrospective studies have led to changes in some of the available guidelines. Important advantages of this study include representativeness of the analyzed cohort to all patients with a specific cancer and a large sample size that provides sufficient statistical power to detect differences across different patient groups. The data extracted from the ROC have the potential to produce knowledge, to guide decision-making, and to manage more effectively the challenges of fighting cancer in our region. The Campania region counts more than 6 million people, and it is characterized by a worst oncological outcome compared to the average data of other Italian region: the ROC platform has the potential to analyze the effect of a public intervention in the field of oncology care. Therefore, the primary aim of this study is to create a retrospective-prospective registry of all cancer patients entering the ROC platform and in a GOM path describing the primary and secondary endpoints.
Interventions
Collection of patient data entered in the ROC platform from the beginning activation of the platform (November 2018) until the date on which the study is approved by the local ethics committee
Collection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee
Sponsors
National Cancer Institute, Naples
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed informed consent * registration in the ROC platform
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of use of the services of the ROC platform | Every 2 months up to 5 years | Frequency of use of the services of the ROC platform |
| Descriptive analysis of each subgroup of patients (subdivision by tumor type) | Every 6 months up to 5 years | Descriptive analysis of each subgroup of patients (subdivision by tumor type) |
| Spatial analysis for each patient | Every year up to 5 years | Spatial analysis for each patient |
| Incidence for each tumor of the patients included in the ROC platform | Every year up to 5 years | Incidence for each tumor of the patients included in the ROC platform |
| Evaluation of the time interval between GOM activities | Every 6 months up to 3 years | Time interval between reporting and taking charge by the GOM, the date diagnosis and the GOM meeting date, the first GOM meeting and the final therapeutic decision, the therapy decision and the therapeutic act, and the request for home assistance and the actual taking in charge by the ASL |
| Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) | Every 6 months up to 5 years | Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) |
| Percentage of patient included in clinical trial | Every 2 months up to 5 years | Percentage of patient included in clinical trial |
| Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate | Every 6 months up to 5 years | Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate |
| Prevalence for each tumor of the patients included in the ROC platform | Every year up to 5 years | Prevalence for each tumor of the patients included in the ROC platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis | Every year up to 5 years | Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis |
| Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit | Every year up to 5 years | Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit |
| Description of pharmacological strategies | Every year up to 5 years | Evaluation of pharmacological strategies |
| Survival analysis for each tumor | Every 2 years up to 6 years | Survival analysis for each tumor |
| Life status assessment for each patient | Every year up to 5 years | Life status assessment for each patient |
| Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path | Every year up to 5 years | Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path |
| Description of diagnostic activities | Every year up to 5 years | Evaluation of diagnostic activities |
| Description of surgical strategies | Every year up to 5 years | Evaluation of surgical strategies |
| Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) | Every 6 months up to 5 years | Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) |
| Description of each surgical approach | Every year up to 5 years | Description of each surgical approach |
| Description of the different surgical techniques among the centers | Every year up to 5 years | Description of the different surgical techniques among the centers |
| Patients' quality of life | Every year up to 5 years | Patients' quality of life using questionnaires |
| Patients' reported outcome | Every year up to 5 years | Patients' reported outcome using questionnaires |
| Patients' satisfaction and evaluation of the diagnostic / therapeutic path | Every year up to 5 years | Patients' satisfaction and evaluation of the diagnostic / therapeutic path using questionnaires |
Countries
Italy
Contacts
Primary ContactSandro Pignata, M.D.
Outcome results
None listed