Allo - Cancer - Thrombosis

Study Overview
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Brief Summary
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Management of venous thromboembolism (VTE) in patients with cancer is complex and require the intervention of many specialized health professionals, in hospital but also at home and during follow-up. The AlloTC project aims to integrate the management of VTE within the multidisciplinary care pathway of the patient with cancer, in order to improve the management of VTE in patients with cancer: optimize treatments and follow-up with appropriate anticoagulants, monitor the implementation of good clinical practice, promote patient involvement and adherence. The objective of this monocentric study is to evaluate the efficiency of the integration of the therapeutic management of VTE into a specific management of patient with cancer and to set up a specialized AlloTC team that coordinates this course of care. For that purpose, the management of VTE and outcome of patients with cancer and VTE will be compared between two periods : traditional management and management with the AlloTC team.

Official Title
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Allo - Cancer - Thrombosis

Conditions
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Cancer, Venous Thromboembolism

Intervention / Treatment
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* Other: Setting up a specific care path AlloTC for management of TVE in patients with cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer or haematological malignancies Venous thromboembolism diagnosis (symptomatic or not) Exclusion Criteria: Life expectancy ≤ 3 months Inability to understand or sign consent Inability to read or understand the French language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Historical cohort<br>Patients with venous thromboembolism and cancer who follow traditional management of venous thromboembolism | |
| AlloTC cohort<br>Patients with venous thromboembolism and cancer who follow AlloTC specific management. AlloTC specific care path way develop a personalized care plan (PPS) and ensure the transmission of data (to all the interlocutors: patients and caregivers) at each step of the patient care path. | Other: Setting up a specific care path AlloTC for management of TVE in patients with cancer<br>* Setting up a specific care path AlloTC for management of TVE in patients with cancer with a specific coordination nurse within the AlloTC multidisciplinary team as a privileged interlocutor for health professionals and patients with the aim of simplifying the care pathways and ensuring a hospital-city interface organized in collaboration with the attending physician, to develop and publicize tools available for patients and caregivers (information documents, patient monitoring protocols, etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with appropriate care of venous thromboembolism | Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with appropriate care of venous thromboembolism | Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines | at inclusion | 
| Percentage of patients with appropriate care of venous thromboembolism | Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines | at 3 months | 
| Number of calls from health professionals to the AlloTC team |  | at 6 months | 
| Number of patients lost to follow-up |  | at 3 months | 
| Number of patients lost to follow-up |  | at 6 months | 
| Number of patients evaluated at multidisciplinary meeting |  | at 3 months | 
| Number of patients evaluated at multidisciplinary meeting |  | at 6 months | 
| Number of patients referred to the coordinating nurse in Oncology service | Number of patients referred to the coordinating nurse in Oncology service to reassess the need for supportive care and involve health professionals (dietitian, social worker, psychologist) | at 6 months | 
| Number of complications | Recurrence of venous thromboembolism and bleeding episodes. | at 3 months | 
| Number of complications | Recurrence of venous thromboembolism and bleeding episodes. | at 6 months | 
| Caregiver satisfaction survey concerning on the AlloTC team and care path |  | at inclusion | 
| Caregiver satisfaction survey concerning on the AlloTC team and care path |  | at 3 months | 
| Caregiver satisfaction survey concerning on the AlloTC team and care path |  | at 6 months | 
| Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan '' |  | at 3 months | 
| Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan '' |  | at 6 months | 
| Number of patients accessing the venous thromboembolism information documents. |  | at 6 months | 
| Percentage of patients who had at least 1 session of specialized therapeutic education |  | at 6 months | 
| Assessment of the quality of life of the patient | The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30' | at inclusion | 
| Assessment of the quality of life of the patient | The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30' | at 3 months | 
| Assessment of the quality of life of the patient | The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30' | at 6 months | 
| Patient satisfaction survey concerning the AlloTC team and care path |  | at inclusion | 
| Patient satisfaction survey concerning the AlloTC team and care path |  | at 3 months | 
| Patient satisfaction survey concerning the AlloTC team and care path |  | at 6 months | 
| Number of hospitalizations in the AlloTC cohort |  | at 3 months | 
| Number of hospitalizations in the AlloTC cohort |  | at 6 months | 
| Hospitalization duration in the AlloTC cohort |  | at 3 months | 
| Hospitalization duration in the AlloTC cohort |  | at 6 months |