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Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer (INCISIVE)

26. juni 2020 opdateret af: University Hospital, Rouen

Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring

With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France according to the latest report from the Institut national du Cancer (INCa). Second leading cause of cancer death in men, its management is a public health problem. According to projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in digestive oncology. These projections can be concluded that the demand for care will continue to be growing.

Medical advances and societal leading to increased life expectancy, have operated a mutation of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases. These changes are causing new challenges for the health system.

To address this problem, it is asked health professionals to adapt the organization of health care delivery to improve efficiency, in a constrained economic environment. To this end, action 4.1 of the cancer plan includes the creation of clinical nursing profession, a proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will be empowered to ensure, under certain conditions, prescription treatments protocolized of follow-up tests, further treatment and support, as well as the extension or adaptation of specific treatments.

This project is a first step, in France, in thinking around new organizations in the supply of care in oncology.

For patients, strengthening their monitoring during chemotherapy, will better know their tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects will help reduce the use of emergency care.

The establishment of such a practitioner will free medical time to handle the most complex patients and perform tasks related to research.

For hospital pharmacies this type of organization will optimize their productivity by anticipating orders for chemotherapy pockets.

This project represents an opportunity to demonstrate the added value of advanced practice nurses in France in the health system and particularly in oncology. It also adds value to clinical expertise nurse and register the profession in the research.

The hypothesis is that the quality and safety of care provided by a nurse practitioner are equivalent to those provided by a doctor at follow-up of patients with gastrointestinal cancer, treated with intravenous chemotherapy.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

754

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Rouen, Frankrig
        • Rekruttering
        • Rouen University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Digestive diagnostic of colorectal cancer.
  • Treatment with intravenous chemotherapy or treatment with concomitant oral and intravenous chemotherapy.
  • Patient beginning a cycle of chemotherapy he had already received chemotherapy sessions or not.
  • Patient aged 18 or over.
  • Patient with predictable life expectancy greater than 3 months.
  • Patient speak and understand the French.
  • Patient having read and understood the information letter and signed the consent form.
  • For women of childbearing age: effective contraception 3 months before the start of treatment and negative blood pregnancy test

Exclusion Criteria:

  • Patient aged over 80.
  • Patient aged under 18.
  • Prognosis committed within 3 months.
  • Pregnant women or breastfeeding.
  • Initial clinical assessment quoting fatigue to a higher grade 2 according to the WHO classification before the start of chemotherapy treatment.
  • Against indication(s) for chemotherapy.
  • Person deprived of liberty by an administrative or judicial decision or person under the protection of a conservator.
  • History of disease or psychological or sensory abnormality that may prevent the patient to understand the requirements for participation in the protocol or preventing it from giving informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nurse practitioner consultation
standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
Andet: Standard consultation
standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of side effects of chemotherapy for WHO grade greater than 2
Tidsramme: Day 7
Day 7

Sekundære resultatmål

Resultatmål
Tidsramme
Quality of life of patients by QLQC-30 questionnaire
Tidsramme: Day 7
Day 7
Number of provisional chemotherapy orders
Tidsramme: Day 7
Day 7

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. december 2016

Primær færdiggørelse (Forventet)

1. december 2020

Studieafslutning (Forventet)

1. december 2020

Datoer for studieregistrering

Først indsendt

3. november 2016

Først indsendt, der opfyldte QC-kriterier

4. november 2016

Først opslået (Skøn)

6. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ColoRektal Cancer

3
Abonner