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

Primary Purpose

ColoRectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
standard chemotherapy for colorectal cancer
Nurse practitioner consultation
Medical practitioner consultation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ColoRectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Nurse practitioner consultation

Standard consultation

Arm Description

standard chemotherapy for colorectal cancer

standard chemotherapy for colorectal cancer

Outcomes

Primary Outcome Measures

Number of side effects of chemotherapy for WHO grade greater than 2

Secondary Outcome Measures

Quality of life of patients by QLQC-30 questionnaire
Number of provisional chemotherapy orders

Full Information

First Posted
November 3, 2016
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02956876
Brief Title
Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer
Acronym
INCISIVE
Official Title
Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ColoRectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
754 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse practitioner consultation
Arm Type
Experimental
Arm Description
standard chemotherapy for colorectal cancer
Arm Title
Standard consultation
Arm Type
Other
Arm Description
standard chemotherapy for colorectal cancer
Intervention Type
Drug
Intervention Name(s)
standard chemotherapy for colorectal cancer
Intervention Description
standard chemotherapy for colorectal cancer
Intervention Type
Other
Intervention Name(s)
Nurse practitioner consultation
Intervention Description
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
Intervention Type
Other
Intervention Name(s)
Medical practitioner consultation
Intervention Description
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.
Primary Outcome Measure Information:
Title
Number of side effects of chemotherapy for WHO grade greater than 2
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Quality of life of patients by QLQC-30 questionnaire
Time Frame
Day 7
Title
Number of provisional chemotherapy orders
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène MAGNIER
Email
helene.magnier@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre MICHEL, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MICHEL, Pr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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