Cancer Clinical Trial
— MinOSOfficial 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.
Verified date | July 2020 |
Source | Groupe Hospitalier Mutualiste de Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 12, 2020 |
Est. primary completion date | May 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Mutualiste de Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Mutualiste de Grenoble | Fondation de l'Avenir |
France,
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Eliasson L, Clifford S, Barber N, Marin D. Exploring chronic myeloid leukemia patients' reasons for not adhering to the oral anticancer drug imatinib as prescribed. Leuk Res. 2011 May;35(5):626-30. doi: 10.1016/j.leukres.2010.10.017. Epub 2010 Nov 20. — View Citation
Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997 Jan;15(1):110-5. — View Citation
Noens L, van Lierde MA, De Bock R, Verhoef G, Zachée P, Berneman Z, Martiat P, Mineur P, Van Eygen K, MacDonald K, De Geest S, Albrecht T, Abraham I. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 2009 May 28;113(22):5401-11. doi: 10.1182/blood-2008-12-196543. Epub 2009 Apr 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients that followed the entirety of MinOS follow-up. | - 91% of included patients must have followed the entirety of MinOS follow up. A patient has followed the entirety of MinOS follow up only if he has attended to each and every one of their 8 scheduled follow up (4 phone calls + 4 consultations) | At the eighth follow-up, which is 8 weeks from baseline, except for Sutent treatment (12 weeks from baseline) | |
Secondary | Toxicity evaluation of targeted oral therapies | - toxicity nature and grade according to CTCAE classification. | 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 | |
Secondary | Evaluation of observance | - Observance score of Morisky | End of the 1st and 2nd treatment cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | |
Secondary | Number of unscheduled phone calls | At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | ||
Secondary | Number of unscheduled hospitalizations | At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | ||
Secondary | Number of private healthcare professionals visit | At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | ||
Secondary | Number of private healthcare professionals' phone call to the hospital | At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | ||
Secondary | Description of the exchange of information between the hospital and independent health professionals | - Evaluation of the utilization of "patients-files": Patients will be asked whether they make use of their "patient-files" and whether they share them with their healthcare professionals, if needed. (YES/NO) | Day 1 of the 1st and 2nd treatment cycles. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | |
Secondary | Description of the patient's independence in regard of his treatment and pathology | - Number of patient's phone call to the hospital | At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks | |
Secondary | Evaluation of patient's satisfaction in regard of MinOS protocol | - Satisfaction survey answered by patients | 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 | |
Secondary | Evaluation of private healthcare professionals' satisfaction in regard of MinOS protocol | - Satisfaction survey answered by private healthcare professionals | 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 | |
Secondary | Evaluation of the quality of life for patients recruited in MinOS protocol | - Score of QLQ-C30 questionnaire | Day 1 of 1st, 2nd and 3rd cycle of treatment. One treatment cycle = 4 weeks, except for Sutent treatment: 1 cycle = 6 weeks | |
Secondary | Number of concomitant drug prescription modification by the hospital pharmacist due to drug interactions with the cancer treatment | - A high number of prescription modification will mean an important part played by the hospital pharmacist, whereas a low number of modification will mean that adding a hospital pharmacist consultation to the standard care isn't relevant. | At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks |
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