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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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