Allo - Cancer - Thrombosis
- Conditions
- CancerVenous Thromboembolism
- Interventions
- Other: Setting up a specific care path "AlloTC" for management of TVE in patients with cancer
- Registration Number
- NCT03563924
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Diagnosis of cancer or haematological malignancies
- Venous thromboembolism diagnosis (symptomatic or not)
- Life expectancy ≤ 3 months
- Inability to understand or sign consent
- Inability to read or understand the French language
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AlloTC cohort Setting up a specific care path "AlloTC" for management of TVE in patients with cancer 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.
- Primary Outcome Measures
Name Time Method Percentage of patients with appropriate care of venous thromboembolism at 6 months Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines
- Secondary Outcome Measures
Name Time Method Number of hospitalizations in the AlloTC cohort 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 6 months Percentage of patients who had at least 1 session of specialized therapeutic education at 6 months Number of complications at 6 months Recurrence of venous thromboembolism and bleeding episodes.
Number of calls from health professionals to the AlloTC team at 6 months Number of patients referred to the coordinating nurse in Oncology service at 6 months 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)
Caregiver satisfaction survey concerning on the AlloTC team and care path at 6 months Hospitalization duration in the AlloTC cohort at 6 months Number of patients lost to follow-up at 6 months Assessment of the quality of life of the patient at 6 months The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'
Percentage of patients with appropriate care of venous thromboembolism at 3 months Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines
Number of patients evaluated at multidisciplinary meeting at 6 months Patient satisfaction survey concerning the AlloTC team and care path at 6 months Number of patients accessing the venous thromboembolism information documents. at 6 months