Clinical trial NCT03563924: Allo - Cancer - Thrombosis
Official title: Allo - Cancer - Thrombosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Venous Thromboembolism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with cancer or hematological malignancy and diagnosed with thromboembolic disease (symptomatic or non-symptomatic).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with appropriate care of venous thromboembolism
timeFrame: at 6 months
Secondary outcomes:
measure: Percentage of patients with appropriate care of venous thromboembolism
timeFrame: at inclusion
measure: Percentage of patients with appropriate care of venous thromboembolism
timeFrame: at 3 months
measure: Number of calls from health professionals to the AlloTC team
timeFrame: at 6 months
measure: Number of patients lost to follow-up
timeFrame: at 3 months
measure: Number of patients lost to follow-up
timeFrame: at 6 months
measure: Number of patients evaluated at multidisciplinary meeting
timeFrame: at 3 months
measure: Number of patients evaluated at multidisciplinary meeting
timeFrame: at 6 months
measure: Number of patients referred to the coordinating nurse in Oncology service
timeFrame: at 6 months
measure: Number of complications
timeFrame: at 3 months
measure: Number of complications
timeFrame: at 6 months
measure: Caregiver satisfaction survey concerning on the AlloTC team and care path
timeFrame: at inclusion
measure: Caregiver satisfaction survey concerning on the AlloTC team and care path
timeFrame: at 3 months
measure: Caregiver satisfaction survey concerning on the AlloTC team and care path
timeFrame: at 6 months
measure: Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan ''
timeFrame: at 3 months
measure: Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan ''
timeFrame: at 6 months
measure: Number of patients accessing the venous thromboembolism information documents.
timeFrame: at 6 months
measure: Percentage of patients who had at least 1 session of specialized therapeutic education
timeFrame: at 6 months
measure: Assessment of the quality of life of the patient
timeFrame: at inclusion
measure: Assessment of the quality of life of the patient
timeFrame: at 3 months
measure: Assessment of the quality of life of the patient
timeFrame: at 6 months
measure: Patient satisfaction survey concerning the AlloTC team and care path
timeFrame: at inclusion
measure: Patient satisfaction survey concerning the AlloTC team and care path
timeFrame: at 3 months
measure: Patient satisfaction survey concerning the AlloTC team and care path
timeFrame: at 6 months
measure: Number of hospitalizations in the AlloTC cohort
timeFrame: at 3 months
measure: Number of hospitalizations in the AlloTC cohort
timeFrame: at 6 months
measure: Hospitalization duration in the AlloTC cohort
timeFrame: at 3 months
measure: Hospitalization duration in the AlloTC cohort
timeFrame: at 6 months
Other outcomes:
Locations:
Study officials:
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