NCT03604666

Brief Summary

The number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. But the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment. The goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital on the increase in the proportion of patients operated on an outpatient basis

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
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

June 10, 2018

Last Update Submit

January 18, 2019

Conditions

Breast CancerSkin CancerSurgeryAmbulatory

Keywords

Breast CancerSkin cancerSurgeryAmbulatory

Outcome Measures

Primary Outcomes (1)

  • Number of patients operated on an outpatient basis

    Test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital

    3 month

Secondary Outcomes (12)

  • Number of death

    at Day 30 and Day 90

  • Number of patients converted to conventional care

    at Day 30 and Day 90

  • Number of the passage to emergencies

    at Day 30 and Day 90

  • Number of not programmed hospitalizations

    at Day 30 and Day 90

  • The autonomy Activities of Daily Living (ADL)

    at Day 30 and Day 90

  • +7 more secondary outcomes

Study Arms (2)

Health care process with Nurse Navigator

A Nurse Navigator will: * Be present at the announcement consultation * Give information on the outpatient circuit * Offer assistance for patients over 75 years * Complete onco-geriatric orientation questionnaires * Take care of patients on the ambulatory circuit

Other: Health care process with Nurse Navigator

Health care process

Health care process

Interventions

Health care process with Nurse NavigatorOTHER

A Nurse Navigator will: * Be present at the announcement consultation * Give information on the outpatient circuit * Offer assistance for patients over 75 years * Complete onco-geriatric orientation questionnaires * Take care of patients on the ambulatory circuit

Health care process with Nurse Navigator

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over 75 years consulting at the dermatological crossroads or "crossroads breast" and requiring surgery for a cancer of the skin or breast (without reconstruction)

You may qualify if:

  • Patient ≥ 75 years old with breast cancer or skin cancer and requiring surgical excision: partial mastectomy, lumpectomy, axillary dissection, cutaneous excision, etc.
  • With an indication of ambulatory care
  • Patient (legal representative or trusted person or member of the family) having been informed and having given his non-oral objection to his participation in the study
  • Possessing a health insurance

You may not qualify if:

  • Patients reserved for breast reconstruction to the operative gesture of tumor resection.
  • Patients do not consent to care because of deficient mental state.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bosc

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsSkin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Romain BOSC, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain BOSC, MD

CONTACT

0149812533romain.bosc@aphp.fr

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

July 27, 2018

Study Start

January 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

January 23, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)