Breast CancerPAPANCT03604666
Follow-up of Elderly Patients in Ambulatory Surgery
An observational study of Breast Cancer and Skin Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Breast Cancer, Skin Cancer, Surgery
- What is being tested?
- Health care process with Nurse Navigator
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bosc
Créteil, 94000
Romain Bosc, MD, 01.49.81.25.33 ext. +33, romainbosc@gmail.com
laetitia Gregoire, 01.49.81.41.64 ext. +33, laetitia.gregoire@aphp.fr
About this study
Official title: 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
- Conditions
- Breast Cancer, Skin Cancer, Surgery, Ambulatory
- Being tested
- Health care process with Nurse Navigator
- Keywords
- Breast Cancer, Skin cancer, Surgery, Ambulatory
- Medical subject headings
- Breast Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care process with Nurse NavigatorOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Health care process with Nurse Navigator | |
| Health care process | Health care process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Secondary outcomes (12)
Number of death
Test the impact of the new organization of care on the mortality
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: at Day 30 and Day 90
Number of postoperative complications
Test the impact of the new organization of care on the postoperative complications
Measured: at Day 90
Costs of care
Test the impact of the new organization of care on the costs of care
Measured: 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
Measured: 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)
Measured: at Day 30 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Jan 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain BOSC, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604666
- Sponsor's protocol ID
- K170702J
- Acronym
- PAPA
- Status last verified
- May 2018
- First submitted
- 10 Jun 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03604666
- Acronym / sponsor ID
- PAPA / K170702J
- Conditions
- Breast Cancer, Skin Cancer, Surgery, Ambulatory
- Keywords
- Breast Cancer, Skin cancer, Surgery, Ambulatory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care process with Nurse Navigator | – | Other: Health care process with Nurse NavigatorA 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 | – | –Health care process |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health care process with Nurse NavigatorA 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 |
Primary outcome
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
12 secondary outcomes
Number of death
Time frame: at Day 30 and Day 90
Number of patients converted to conventional care
Time frame: at Day 30 and Day 90
Number of the passage to emergencies
Time frame: at Day 30 and Day 90
Number of not programmed hospitalizations
Time frame: at Day 30 and Day 90
The autonomy Activities of Daily Living (ADL)
Time frame: at Day 30 and Day 90
The autonomy Instrumental Activities of Daily Living (IADL)
Time frame: 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
Number of passage to Long-term care and skilled nursing facilities
Time frame: at Day 30 and Day 90
Number of postoperative complications
Time frame: at Day 90
Costs of care
Time frame: at Day 30 and Day 90
Patients' satisfaction (questionnaire) for the prospective part of the study
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain BOSC, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Skin Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain BOSC, MD (0149812533 ext. +33, romain.bosc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients operated on an outpatient basis (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.