Follow-up of Elderly Patients in Ambulatory Surgery

Breast Cancer Clinical Trial

— PAPA  

Official title:

Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03604666
• Other study ID #: K170702J
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Romain BOSC, MD
• Phone: 0149812533
• Email: romain.bosc[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory
• Breast Cancer
• Breast Neoplasms
• Skin Cancer
• Skin Neoplasms
• Surgery

Intervention

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

Locations

Country	Name	City	State
France	Bosc	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of death	Test the impact of the new organization of care on the mortality	at Day 30 and Day 90
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of postoperative complications	Test the impact of the new organization of care on the postoperative complications	at Day 90
Secondary	Costs of care	Test the impact of the new organization of care on the costs of care	at Day 30 and Day 90
Secondary	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
Secondary	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