Back to resultsPilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer (PITCA)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dedicated and coordinated e-follow-up.
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Ambulatory surgery, Electronic tool, e-follow-up
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Institut Claudius Regaud IUCT-ONCOPOLE
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with breast cancer operated in ambulatory
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient satisfaction to the e-follow-up.
Satisfaction will be evaluated by questionnaire.
The rate of patients who discontinue the study 8 days before the surgery.
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.
Rate of patients with at least one unplanned visit.
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.
Full Information
NCT ID
NCT03289286
First Posted
September 18, 2017
Last Updated
August 3, 2018
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT03289286
Brief Title
Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
Acronym
PITCA
Official Title
Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 post-surgery
Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Ambulatory surgery, Electronic tool, e-follow-up
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with breast cancer operated in ambulatory
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Dedicated and coordinated e-follow-up.
Intervention Description
In pre- and post-surgery:
Completion of questionnaires using an electronic tool,
Telephone follow-up if necessary between the nurse and the patient.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Patient satisfaction to the e-follow-up.
Description
Satisfaction will be evaluated by questionnaire.
Time Frame
1.5 months by patient
Title
The rate of patients who discontinue the study 8 days before the surgery.
Time Frame
1.5 months by patient
Title
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
Title
Rate of patients with at least one unplanned visit.
Time Frame
1.5 months by patient
Title
The time spent by the dedicated nurse for the follow-up protocol management.
Description
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.
Time Frame
1.5 months by patient
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri GANGLOFF
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Claudius Regaud IUCT-ONCOPOLE
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer
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