Clinical trial NCT03454971: Health Course of Patients Undergoing Per os Anti-cancer Therapy.
Official title: Multidisciplinary Consultation at the GHM Hospital of Grenoble (France) for the Establishment of an Oral Anti-cancer Drug Therapy : Feasibility, Security, and Evaluation of Patients' and City Health Professionals' Satisfaction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Groupe Hospitalier Mutualiste de Grenoble
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2018-03-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients that followed the entirety of MinOS follow-up.
timeFrame: At the eighth follow-up, which is 8 weeks from baseline, except for Sutent treatment (12 weeks from baseline)
Secondary outcomes:
measure: Toxicity evaluation of targeted oral therapies
timeFrame: Day 8 and 15 of 1st treatment cycle ; Day 1, 8 and 15 of 2nd treatment cycle ; Day 1 of 3rd treatment cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Evaluation of observance
timeFrame: End of the 1st and 2nd treatment cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Number of unscheduled phone calls
timeFrame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Number of unscheduled hospitalizations
timeFrame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Number of private healthcare professionals visit
timeFrame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Number of private healthcare professionals' phone call to the hospital
timeFrame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Description of the exchange of information between the hospital and independent health professionals
timeFrame: Day 1 of the 1st and 2nd treatment cycles. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Description of the patient's independence in regard of his treatment and pathology
timeFrame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Evaluation of patient's satisfaction in regard of MinOS protocol
timeFrame: At the end of the patient's therapy within MinOS framework (end of cycle 2). One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Evaluation of private healthcare professionals' satisfaction in regard of MinOS protocol
timeFrame: At the end of the patient's therapy within MinOS framework (end of cycle 2). One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
measure: Evaluation of the quality of life for patients recruited in MinOS protocol
timeFrame: Day 1 of 1st, 2nd and 3rd cycle of treatment. One treatment cycle = 4 weeks, except for Sutent treatment: 1 cycle = 6 weeks
measure: Number of concomitant drug prescription modification by the hospital pharmacist due to drug interactions with the cancer treatment
timeFrame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
Study officials:
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