NCT04209491

Brief Summary

This project is based on the assumption that the nurse coordinators of the centres have common missions at each of the key stages of patient care. These missions make the care plan more fluid and improve the quality and safety of care as well as the patient's prognosis. The Hypothesis is that co-follow-up by a doctor and a nurse coordinator reduces time between referral to treatment, average lengths of stay, unscheduled readmissions or early emergency visits, compared to follow-up that does not involve a nurse coordinator.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 9, 2020

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

December 20, 2019

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of the following missions of the coordinator Nurse

    missions: o Initial contact of the patient with the expert centre * Organisation of the MDT meeting * Organisation of treatment and investigations * Coordination between hospital professionals * Link with community health professionals * Follow-up (post-hospitalization, treatment side effects, etc.) * Information, advice to patients * Psychological support * Implementation of care pathways * Nursing research

    12 months

Secondary Outcomes (8)

  • Timeframe in days between The first contact with the centre and the first interventional radiology treatment.

    12 months

  • Timeframe in days between : The first contact with the centre and the first presentation at a MDT meeting

    12 months

  • Timeframe in days between : The first contact with the centre and the diagnostic consultation

    12 months

  • Timeframe in days between :The first contact with the centre and discharge from the hospital

    12 months

  • Timeframe in days between :The interventional radiology procedure and the next one for the subgroup of patients who have multiple procedures during the follow-up period

    12 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with a diagnosis of localized hepatocellular carcinoma.

You may qualify if:

  • Centre with interventional radiology treatment
  • Active list of patients followed for a HCC of at least 70 / year
  • Reply to the feasibility questionnaire within 60 days from receipt of the email

You may not qualify if:

  • Patient with a localized HCC diagnosis (BCLC A or B)
  • Hospitalised for a first interventional radiology treatment (radioembolisation, transarterial chemoembolization or percutaneous ablation) in one of the centres included in the study between July 1, 2017 and December 31, 2017

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BEAUJON Hospital

Clichy-sous-Bois, 92110, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Julie DEVICTOR

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie JD DEVICTOR

CONTACT

Mohamed MB BOUATTOUR, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

September 9, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 9, 2020

Record last verified: 2019-12

Locations