Allo - Cancer - Thrombosis
AlloTC
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 10, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJune 20, 2018
June 1, 2018
6 months
June 10, 2018
June 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (27)
Percentage of patients with appropriate care of venous thromboembolism
at inclusion
Percentage of patients with appropriate care of venous thromboembolism
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
- +22 more secondary outcomes
Study Arms (2)
Historical cohort
Patients with venous thromboembolism and cancer who follow traditional management of venous thromboembolism
AlloTC cohort
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.
Interventions
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.)
Eligibility Criteria
All adult patients with cancer or hematological malignancy and diagnosed with thromboembolic disease (symptomatic or non-symptomatic).
You may qualify if:
- Diagnosis of cancer or haematological malignancies
- Venous thromboembolism diagnosis (symptomatic or not)
You may not qualify if:
- Life expectancy ≤ 3 months
- Inability to understand or sign consent
- Inability to read or understand the French language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2018
First Posted
June 20, 2018
Study Start
June 1, 2018
Primary Completion
December 1, 2018
Study Completion
September 1, 2019
Last Updated
June 20, 2018
Record last verified: 2018-06