Allo - Cancer - Thrombosis

Cancer Clinical Trial

— AlloTC  

Official title:

Allo - Cancer - Thrombosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03563924
• Other study ID #: K171103J
• Status: Not yet recruiting
• Start date: June 2018
• Est. completion date: September 2019

Study information

• Verified date: June 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dominique Farge
• Phone: +33142499768
• Email: dominique.farge-bancel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Thrombosis
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 inclusion
Secondary	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 3 months
Secondary	Number of calls from health professionals to the AlloTC team		at 6 months
Secondary	Number of patients lost to follow-up		at 3 months
Secondary	Number of patients lost to follow-up		at 6 months
Secondary	Number of patients evaluated at multidisciplinary meeting		at 3 months
Secondary	Number of patients evaluated at multidisciplinary meeting		at 6 months
Secondary	Number of patients referred to the coordinating nurse in Oncology service	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
Secondary	Number of complications	Recurrence of venous thromboembolism and bleeding episodes.	at 3 months
Secondary	Number of complications	Recurrence of venous thromboembolism and bleeding episodes.	at 6 months
Secondary	Caregiver satisfaction survey concerning on the AlloTC team and care path		at inclusion
Secondary	Caregiver satisfaction survey concerning on the AlloTC team and care path		at 3 months
Secondary	Caregiver satisfaction survey concerning on the AlloTC team and care path		at 6 months
Secondary	Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan ''		at 3 months
Secondary	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
Secondary	Number of patients accessing the venous thromboembolism information documents.		at 6 months
Secondary	Percentage of patients who had at least 1 session of specialized therapeutic education		at 6 months
Secondary	Assessment of the quality of life of the patient	The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'	at inclusion
Secondary	Assessment of the quality of life of the patient	The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'	at 3 months
Secondary	Assessment of the quality of life of the patient	The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'	at 6 months
Secondary	Patient satisfaction survey concerning the AlloTC team and care path		at inclusion
Secondary	Patient satisfaction survey concerning the AlloTC team and care path		at 3 months
Secondary	Patient satisfaction survey concerning the AlloTC team and care path		at 6 months
Secondary	Number of hospitalizations in the AlloTC cohort		at 3 months
Secondary	Number of hospitalizations in the AlloTC cohort		at 6 months
Secondary	Hospitalization duration in the AlloTC cohort		at 3 months
Secondary	Hospitalization duration in the AlloTC cohort		at 6 months