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Completed

NCT Number: NCT03289286

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Claudius Regaud IUCT-ONCOPOLE

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 1.5 months by patient

    Satisfaction will be evaluated by questionnaire.

  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.

    Time frame: 1.5 months by patient

    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.

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: PITCA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2017
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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