Breast CancerPITCANCT03289286
Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
A study testing Dedicated and coordinated e-follow-up. in people with Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer. This protocol will be based on: A coordinated ambulatory follow-up performed by a dedicated nurse An electronic follow-up tool used in pre- and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dedicated and coordinated e-follow-up.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2017to 29 Jun 2018
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling)
- Ambulatory surgery planned 10 days or more after inclusion date
- Age > or = 18 years old
- Affiliated to the french social security system
- Patient must provide written informed consent prior to any study-specific procedure or assessment
Who cannot join
- Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities)
- Patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection)
- Pregnant or breastfeeding women
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.
This protocol will be based on:
- A coordinated ambulatory follow-up performed by a dedicated nurse
- An electronic follow-up tool used in pre- and post-surgery
Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Dedicated and coordinated e-follow-up.
- Keywords
- Breast Cancer, Ambulatory surgery, Electronic tool, e-follow-up
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated and coordinated e-follow-up.Other
In pre- and post-surgery:
- Completion of questionnaires using an electronic tool,
- Telephone follow-up if necessary between the nurse and the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer operated in ambulatory | Other | Not described Receives: Other: Dedicated and coordinated e-follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications.
Measured: 1.5 months by patient
Secondary outcomes (5)
Patient satisfaction to the e-follow-up.
Satisfaction will be evaluated by questionnaire.
Measured: 1.5 months by patient
The rate of patients who discontinue the study 8 days before the surgery.
Measured: 1.5 months by patient
The number of unplanned visits into the Center after ambulatory surgery in the first 24 hours and during the first 30 days will be assessed for each patient.
Measured: 1.5 months by patient
Rate of patients with at least one unplanned visit.
Measured: 1.5 months by patient
The time spent by the dedicated nurse for the follow-up protocol management.
It will be defined as the sum of the time spent at different stages: initial training of patients, tracking of the connections to the tool, tracking of the alerts and telephone contacts.
Measured: 1.5 months by patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start17 Nov 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri GANGLOFF, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289286
- Sponsor's protocol ID
- 17SEIN04
- Acronym
- PITCA
- Status last verified
- Aug 2018
- First submitted
- 18 Sep 2017
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
- ClinicalTrials.gov ID
- NCT03289286
- Acronym / sponsor ID
- PITCA / 17SEIN04
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Ambulatory surgery, Electronic tool, e-follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 20 Sep 2017 (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.
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.
This protocol will be based on:
- A coordinated ambulatory follow-up performed by a dedicated nurse
- An electronic follow-up tool used in pre- and post-surgery
Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer operated in ambulatory | Other | Other: Dedicated and coordinated e-follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling)
- Ambulatory surgery planned 10 days or more after inclusion date
- Age > or = 18 years old
- Affiliated to the french social security system
- Patient must provide written informed consent prior to any study-specific procedure or assessment
Key exclusion criteria (5 listed)
- Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities)
- Patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection)
- Pregnant or breastfeeding women
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient protected by law
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 |
|---|---|---|
| Dedicated and coordinated e-follow-up.In pre- and post-surgery: * Completion of questionnaires using an electronic tool, * Telephone follow-up if necessary between the nurse and the patient. | Other | Patients with breast cancer operated in ambulatory |
Primary outcome
Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications.
Time frame: 1.5 months by patient
5 secondary outcomes
Patient satisfaction to the e-follow-up.
Time frame: 1.5 months by patient
The rate of patients who discontinue the study 8 days before the surgery.
Time frame: 1.5 months by patient
The number of unplanned visits into the Center after ambulatory surgery in the first 24 hours and during the first 30 days will be assessed for each patient.
Time frame: 1.5 months by patient
Rate of patients with at least one unplanned visit.
Time frame: 1.5 months by patient
The time spent by the dedicated nurse for the follow-up protocol management.
Time frame: 1.5 months by patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
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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.
Dimitri GANGLOFF principal investigator
Institut Claudius Regaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dedicated and coordinated e-follow-up. in people with Breast Cancer, run by Institut Claudius Regaud 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications. (time frame: 1.5 months by patient). 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 6 Aug 2018; AzTrials last refreshed its copy on 28 Oct 2026.