Allo - Cancer - Thrombosis (AlloTC)
June 10, 2018 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adult patients with cancer or hematological malignancy and diagnosed with thromboembolic disease (symptomatic or non-symptomatic).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients with appropriate care of venous thromboembolism
Time Frame: at 6 months
|
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
Time Frame: at inclusion
|
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
Time Frame: at 3 months
|
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
Time Frame: at 6 months
|
at 6 months
|
|
|
Number of patients lost to follow-up
Time Frame: at 3 months
|
at 3 months
|
|
|
Number of patients lost to follow-up
Time Frame: at 6 months
|
at 6 months
|
|
|
Number of patients evaluated at multidisciplinary meeting
Time Frame: at 3 months
|
at 3 months
|
|
|
Number of patients evaluated at multidisciplinary meeting
Time Frame: at 6 months
|
at 6 months
|
|
|
Number of patients referred to the coordinating nurse in Oncology service
Time Frame: 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)
|
at 6 months
|
|
Number of complications
Time Frame: at 3 months
|
Recurrence of venous thromboembolism and bleeding episodes.
|
at 3 months
|
|
Number of complications
Time Frame: at 6 months
|
Recurrence of venous thromboembolism and bleeding episodes.
|
at 6 months
|
|
Caregiver satisfaction survey concerning on the AlloTC team and care path
Time Frame: at inclusion
|
at inclusion
|
|
|
Caregiver satisfaction survey concerning on the AlloTC team and care path
Time Frame: at 3 months
|
at 3 months
|
|
|
Caregiver satisfaction survey concerning on the AlloTC team and care path
Time Frame: at 6 months
|
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 ''
Time Frame: at 3 months
|
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 ''
Time Frame: at 6 months
|
at 6 months
|
|
|
Number of patients accessing the venous thromboembolism information documents.
Time Frame: at 6 months
|
at 6 months
|
|
|
Percentage of patients who had at least 1 session of specialized therapeutic education
Time Frame: at 6 months
|
at 6 months
|
|
|
Assessment of the quality of life of the patient
Time Frame: at inclusion
|
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
Time Frame: at 3 months
|
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
Time Frame: at 6 months
|
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
Time Frame: at inclusion
|
at inclusion
|
|
|
Patient satisfaction survey concerning the AlloTC team and care path
Time Frame: at 3 months
|
at 3 months
|
|
|
Patient satisfaction survey concerning the AlloTC team and care path
Time Frame: at 6 months
|
at 6 months
|
|
|
Number of hospitalizations in the AlloTC cohort
Time Frame: at 3 months
|
at 3 months
|
|
|
Number of hospitalizations in the AlloTC cohort
Time Frame: at 6 months
|
at 6 months
|
|
|
Hospitalization duration in the AlloTC cohort
Time Frame: at 3 months
|
at 3 months
|
|
|
Hospitalization duration in the AlloTC cohort
Time Frame: at 6 months
|
at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2018
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
June 10, 2018
First Submitted That Met QC Criteria
June 10, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
June 20, 2018
Last Update Submitted That Met QC Criteria
June 10, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K171103J
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.