CancerAlloTCNCT03563924
Allo - Cancer - Thrombosis
An observational study of Cancer and Venous Thromboembolism, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Venous Thromboembolism
- What is being tested?
- Setting up a specific care path "AlloTC" for management of TVE in patients with cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with cancer or hematological malignancy and diagnosed with thromboembolic disease (symptomatic or non-symptomatic).
Who may be able to join
- Diagnosis of cancer or haematological malignancies
- Venous thromboembolism diagnosis (symptomatic or not)
Who cannot join
- Life expectancy ≤ 3 months
- Inability to understand or sign consent
- Inability to read or understand the French language
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Conditions
- Cancer, Venous Thromboembolism
- Being tested
- Setting up a specific care path "AlloTC" for management of TVE in patients with cancer
- Medical subject headings
- Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setting up a specific care path "AlloTC" for management of TVE in patients with cancerOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Setting up a specific care path "AlloTC" for management of TVE in patients with cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6 months
Secondary outcomes (27)
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
Measured: at inclusion
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
Measured: at 3 months
Number of calls from health professionals to the AlloTC team
Measured: at 6 months
Number of patients lost to follow-up
Measured: at 3 months
Number of patients lost to follow-up
Measured: at 6 months
Number of patients evaluated at multidisciplinary meeting
Measured: at 3 months
Number of patients evaluated at multidisciplinary meeting
Measured: at 6 months
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)
Measured: at 6 months
Number of complications
Recurrence of venous thromboembolism and bleeding episodes.
Measured: at 3 months
Number of complications
Recurrence of venous thromboembolism and bleeding episodes.
Measured: at 6 months
Caregiver satisfaction survey concerning on the AlloTC team and care path
Measured: at inclusion
Caregiver satisfaction survey concerning on the AlloTC team and care path
Measured: at 3 months
Caregiver satisfaction survey concerning on the AlloTC team and care path
Measured: 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 ''
Measured: 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 ''
Measured: at 6 months
Number of patients accessing the venous thromboembolism information documents.
Measured: at 6 months
Percentage of patients who had at least 1 session of specialized therapeutic education
Measured: at 6 months
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'
Measured: at inclusion
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'
Measured: at 3 months
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'
Measured: at 6 months
Patient satisfaction survey concerning the AlloTC team and care path
Measured: at inclusion
Patient satisfaction survey concerning the AlloTC team and care path
Measured: at 3 months
Patient satisfaction survey concerning the AlloTC team and care path
Measured: at 6 months
Number of hospitalizations in the AlloTC cohort
Measured: at 3 months
Number of hospitalizations in the AlloTC cohort
Measured: at 6 months
Hospitalization duration in the AlloTC cohort
Measured: at 3 months
Hospitalization duration in the AlloTC cohort
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563924
- Sponsor's protocol ID
- K171103J
- Acronym
- AlloTC
- Status last verified
- Jun 2018
- First submitted
- 10 Jun 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allo - Cancer - Thrombosis
- ClinicalTrials.gov ID
- NCT03563924
- Acronym / sponsor ID
- AlloTC / K171103J
- Conditions
- Cancer, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical cohort | – | –Patients with venous thromboembolism and cancer who follow traditional management of venous thromboembolism |
| AlloTC cohort | – | Other: Setting up a specific care path "AlloTC" for management of TVE in patients with cancerPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with cancer or hematological malignancy and diagnosed with thromboembolic disease (symptomatic or non-symptomatic).
Key inclusion criteria (2 listed)
- Diagnosis of cancer or haematological malignancies
- Venous thromboembolism diagnosis (symptomatic or not)
Key exclusion criteria (3 listed)
- Life expectancy ≤ 3 months
- Inability to understand or sign consent
- Inability to read or understand the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Setting up a specific care path "AlloTC" for management of TVE in patients with cancerSetting 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.) | Other | AlloTC cohort |
Primary outcome
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
27 secondary outcomes
Percentage of patients with appropriate care of venous thromboembolism
Time frame: at inclusion
Percentage of patients with appropriate care of venous thromboembolism
Time frame: at 3 months
Number of calls from health professionals to the AlloTC team
Time frame: at 6 months
Number of patients lost to follow-up
Time frame: at 3 months
Number of patients lost to follow-up
Time frame: at 6 months
Number of patients evaluated at multidisciplinary meeting
Time frame: at 3 months
Number of patients evaluated at multidisciplinary meeting
Time frame: at 6 months
Number of patients referred to the coordinating nurse in Oncology service
Time frame: at 6 months
Number of complications
Time frame: at 3 months
Number of complications
Time frame: at 6 months
Caregiver satisfaction survey concerning on the AlloTC team and care path
Time frame: at inclusion
Caregiver satisfaction survey concerning on the AlloTC team and care path
Time frame: at 3 months
Caregiver satisfaction survey concerning on the AlloTC team and care path
Time frame: 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
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
Number of patients accessing the venous thromboembolism information documents.
Time frame: at 6 months
Percentage of patients who had at least 1 session of specialized therapeutic education
Time frame: at 6 months
Assessment of the quality of life of the patient
Time frame: at inclusion
Assessment of the quality of life of the patient
Time frame: at 3 months
Assessment of the quality of life of the patient
Time frame: at 6 months
Patient satisfaction survey concerning the AlloTC team and care path
Time frame: at inclusion
Patient satisfaction survey concerning the AlloTC team and care path
Time frame: at 3 months
Patient satisfaction survey concerning the AlloTC team and care path
Time frame: at 6 months
Number of hospitalizations in the AlloTC cohort
Time frame: at 3 months
Number of hospitalizations in the AlloTC cohort
Time frame: at 6 months
Hospitalization duration in the AlloTC cohort
Time frame: at 3 months
Hospitalization duration in the AlloTC cohort
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Venous Thromboembolism, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Farge (+33142499768, dominique.farge-bancel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with appropriate care of venous thromboembolism (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.