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CompletedNCT03289286PITCAUpdated Aug 6, 2018

Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer

An interventional study of Dedicated and coordinated e-follow-up. in Breast Cancer, sponsored by Institut Claudius Regaud. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-06.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
  • Ambulatory surgery
  • Electronic tool
  • e-follow-up
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with or without lymph node sampling)
  2. Ambulatory surgery planned 10 days or more after inclusion date
  3. Age > or = 18 years old
  4. Affiliated to the french social security system
  5. Patient must provide written informed consent prior to any study-specific procedure or assessment

Exclusion criteria

Exclusion Criteria:

  1. Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other surgical specialities)
  2. Patient who cannot connect to the electronic tool at home (no computer, no tablet computer or no internet connection)
  3. Pregnant or breastfeeding women
  4. 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
  5. Patient protected by law
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Other
    Patients with breast cancer operated in ambulatory

    Other: Dedicated and coordinated e-follow-up.

Interventions

  • OtherDedicated 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.

05

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Patient satisfaction to the e-follow-up.

    Satisfaction will be evaluated by questionnaire.

    Time frame: 1.5 months by patient

  2. The rate of patients who discontinue the study 8 days before the surgery.

    Time frame: 1.5 months by patient

  3. 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

  4. Rate of patients with at least one unplanned visit.

    Time frame: 1.5 months by patient

  5. 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.

    Time frame: 1.5 months by patient

06

Study locations

1 site
  • Institut Claudius Regaud IUCT-ONCOPOLE
    Toulouse, 31059, France
07

Registry details

Key details

Study ID
NCT03289286
Lead sponsor
Institut Claudius Regaud
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Nov 17, 2017
Primary completion
Jun 29, 2018
Completion
Jun 29, 2018
Last update
Aug 6, 2018

Study contacts

Dimitri GANGLOFF
principal investigator · Institut Claudius Regaud

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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