Health Course of Patients Undergoing Per os Anti-cancer Therapy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2020-05-12

Brief Summary

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During the last few years, the medical care of oncohematologic cancers diagnosed patients was shaken by the arrival of new therapies : targeted therapies. Very efficient, these therapies use the oral pathway in most cases, and are taken at home. These treatments show plenty of drug interactions and side effects aren't rare and require, in their own, a rigorous follow up in order to reduce their occurrence, intensity and their impact on patients' quality of life. A bad management of the treatment could lead to an inacceptable toxicity, or to its premature interruption.

With all the new administration and follow up strains in mind, we want to elaborate the medical pathway structure for these patients by reinforcing the nurse coordination and by integrating another healthcare professional : the hospital pharmacist, which is a professional especially implicated in the drug delivery, the control of drug interactions and medical advices relative to the given drug.

Private healthcare professionals (referring physicians, pharmacists, private nurses), unsufficiently trained and informed about these new treatments and their side effects, are asking for further information concerning the drugs prescribed to their patients, and are willing to keep open a communication line for the home follow up.

These patients, who are autonomously taking their medication, are in need to be informed and supported to insure the good management of the drug, while taking in account their environment, their knowledge of their cancer and treatment and also of all the issues that could occur during their therapy, in order to resolve them.

We propose a multidisciplinary medical care taking place at the very beginning of an oral therapy treatment, in order to ensure the security of the drug administration. Patients and healthcare professionals will be closely followed during the first two treatment cycles. After this, side-effects incidence are less frequent and the usual oncohematologic follow up is sufficient.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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MinOS arm

Patients are followed according to MinOS protocol:

Group Type EXPERIMENTAL

MinOS protocol

Intervention Type OTHER

At Day 1, Cycle 1 and 2 of the patient's oral therapy :

* Consultation with a hospital pharmacist
* Consultation with a nurse care coordinator
* Consultation with the patient's oncologist/hematologist

During this multidisciplinary consultation, will be reviewed :

* potential medical interactions,
* possible adverse effects of therapy,
* information on the prescribed drug,
* informations on the patient's lifestyle, ...

At day 8 and 15, cycle 1 and 2 :

Phone call from the nurse care coordinator during which will be reported the adverse effects and adherence issues. If needed, the nurse care coordinator can provide complementary information about the treatment.

The MINOS protocol follow up will end with a consultation with the patient's oncologist/hematologist, at day 1 cycle 3.

Interventions

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MinOS protocol

At Day 1, Cycle 1 and 2 of the patient's oral therapy :

* Consultation with a hospital pharmacist
* Consultation with a nurse care coordinator
* Consultation with the patient's oncologist/hematologist

During this multidisciplinary consultation, will be reviewed :

* potential medical interactions,
* possible adverse effects of therapy,
* information on the prescribed drug,
* informations on the patient's lifestyle, ...

At day 8 and 15, cycle 1 and 2 :

Phone call from the nurse care coordinator during which will be reported the adverse effects and adherence issues. If needed, the nurse care coordinator can provide complementary information about the treatment.

The MINOS protocol follow up will end with a consultation with the patient's oncologist/hematologist, at day 1 cycle 3.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient who treated at the Groupe Hospitalier Mutualiste for an oncohematological pathology, and for which targeted oral therapy is indicated (Tarceva, Afinitor, Sutent, Ibrance, Revlimid, Zydelig, Imbruvica)
* Patient who has given its written consent
* Patient affiliated or beneficiary of social security system

Exclusion Criteria

* ECOG performance score \< 2
* Patient already included in an interventional clinical research protocol
* Patients protected by French law from clinical research inclusion (pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No