Follow-up of Elderly Patients in Ambulatory Surgery

• Conditions: Breast Cancer; Ambulatory; Skin Cancer; Surgery
• Interventions: Other: Health care process with Nurse Navigator

• Registration Number: NCT03604666
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-05
• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-27
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health care process with Nurse Navigator	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

Primary Outcome Measures

Name	Time	Method
Number of patients operated on an outpatient basis	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bosc; 🇫🇷 Créteil, France