CClinicalTrials.gg
Status unknownNCT03604666PAPAUpdated Jan 23, 2019

Follow-up of Elderly Patients in Ambulatory Surgery

An observational study in Breast Cancer, Skin Cancer and Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
320
Ages
75 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Breast Cancer
  • Skin Cancer
  • Surgery
  • Ambulatory

Keywords

  • Breast Cancer
  • Skin cancer
  • Surgery
  • Ambulatory
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 320 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
320 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Health care process

    Health care process

Interventions

  • OtherHealth 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 month

Secondary outcomes

  1. Number of death

    Test the impact of the new organization of care on the mortality

    Time frame: at Day 30 and Day 90

  2. 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

    Time frame: at Day 30 and Day 90

  3. Number of the passage to emergencies

    Test the impact of the new organization of care on the passage to emergencies

    Time frame: at Day 30 and Day 90

  4. Number of not programmed hospitalizations

    Test the impact of the new organization of care on the not programmed hospitalizations

    Time frame: at Day 30 and Day 90

  5. The autonomy Activities of Daily Living (ADL)

    Test the impact of the new organization of care on the autonomy (ADL/IADL)

    Time frame: at Day 30 and Day 90

  6. The autonomy Instrumental Activities of Daily Living (IADL)

    Test the impact of the new organization of care on the autonomy (ADL/IADL)

    Time frame: at Day 30 and Day 90

  7. 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

    Time frame: at Day 30 and Day 90

  8. 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

    Time frame: at Day 30 and Day 90

  9. Number of postoperative complications

    Test the impact of the new organization of care on the postoperative complications

    Time frame: at Day 90

  10. Costs of care

    Test the impact of the new organization of care on the costs of care

    Time frame: at Day 30 and Day 90

  11. Patients' satisfaction (questionnaire) for the prospective part of the study

    Test the impact of the new organization of care on patients' satisfaction

    Time frame: at Day 30 and Day 90

  12. 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)

    Time frame: at Day 30 and Day 90

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03604666
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 27, 2018
Start date
Jan 1, 2018
Primary completion
Mar 1, 2019 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Jan 23, 2019

Study contacts

Romain BOSC, MD
Contact
romain.bosc@aphp.fr
0149812533 ext. +33
Romain BOSC, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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