NCT03563924

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Status
unknown

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

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 10, 2018

Last Update Submit

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.

Other: Setting up a specific care path "AlloTC" for management of TVE in patients with cancer

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.)

AlloTC cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

NeoplasmsVenous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

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