Follow-up of Elderly Patients in Ambulatory Surgery (PAPA)

January 18, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients reserved for breast reconstruction to the operative gesture of tumor resection.
  • Patients do not consent to care because of deficient mental state.
  • Formal surgical contraindication due to a pathology medical device does not allow anesthesia. - Participation in another interventional research or be in the exclusion period after a previous search, if applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients operated on an outpatient basis
Time Frame: 3 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of death
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the mortality
at Day 30 and Day 90
Number of patients converted to conventional care
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the proportion of patients converted to conventional care
at Day 30 and Day 90
Number of the passage to emergencies
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the passage to emergencies
at Day 30 and Day 90
Number of not programmed hospitalizations
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the not programmed hospitalizations
at Day 30 and Day 90
The autonomy Activities of Daily Living (ADL)
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the autonomy (ADL/IADL)
at Day 30 and Day 90
The autonomy Instrumental Activities of Daily Living (IADL)
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the autonomy (ADL/IADL)
at Day 30 and Day 90
Number of institutionalization to Long-term care and skilled nursing facilities
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the institutionalization to Long-term care and skilled nursing facilities
at Day 30 and Day 90
Number of passage to Long-term care and skilled nursing facilities
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the passage to Long-term care and skilled nursing facilities
at Day 30 and Day 90
Number of postoperative complications
Time Frame: at Day 90
Test the impact of the new organization of care on the postoperative complications
at Day 90
Costs of care
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on the costs of care
at Day 30 and Day 90
Patients' satisfaction (questionnaire) for the prospective part of the study
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on patients' satisfaction
at Day 30 and Day 90
Patient's quality of life (EQ50 questionnaire, for the prospective part of the study)
Time Frame: at Day 30 and Day 90
Test the impact of the new organization of care on quality of life (EQ50) (for the prospective part of the study)
at Day 30 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Romain BOSC, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

June 10, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K170702J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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