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

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: Breast Cancer; Surgery; Skin Cancer; Ambulatory
• Intervention / Treatment: Other: Health care process with Nurse Navigator

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

• Study Contact: Name: Romain BOSC, MD; Phone Number: +33 0149812533; Email: romain.bosc@aphp.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Bosc
    • Contact: Romain Bosc, MD; Phone Number: +33 01.49.81.25.33; Email: romainbosc@gmail.com
    • Contact: laetitia Gregoire; Phone Number: +33 01.49.81.41.64; Email: laetitia.gregoire@aphp.fr

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	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	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	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	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)	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)	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	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	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	Test the impact of the new organization of care on the postoperative complications	at Day 90
Costs of care	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	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)	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

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

Study record dates

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: Breast Cancer; Surgery; Skin cancer; Ambulatory
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Skin Neoplasms
• 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