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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: MinOS protocol

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38028
    • Groupe hospitalier mutualiste de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MinOS arm; Patients are followed according to MinOS protocol:

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of unscheduled hospitalizations		At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Mutualiste de Grenoble
• Collaborators: Fondation de l'Avenir

Publications and helpful links

General Publications

• 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. doi: 10.1200/JCO.1997.15.1.110.
• Noens L, van Lierde MA, De Bock R, Verhoef G, Zachee 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.
• 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.
• Compaci G, Ysebaert L, Oberic L, Derumeaux H, Laurent G. Effectiveness of telephone support during chemotherapy in patients with diffuse large B cell lymphoma: the Ambulatory Medical Assistance (AMA) experience. Int J Nurs Stud. 2011 Aug;48(8):926-32. doi: 10.1016/j.ijnurstu.2011.01.008. Epub 2011 Feb 23.
• Compaci G, Rueter M, Lamy S, Oberic L, Recher C, Lapeyre-Mestre M, Laurent G, Despas F. Ambulatory Medical Assistance--After Cancer (AMA-AC): A model for an early trajectory survivorship survey of lymphoma patients treated with anthracycline-based chemotherapy. BMC Cancer. 2015 Oct 24;15:781. doi: 10.1186/s12885-015-1815-7.

Helpful Links

• [Cancer National Institut. Plan Cancer 2014-2019] (French). Febr 2015.
• [Oncorif. White book : Organisation and care of patient undergoing oral targeted therapy in hematology] (french). Nov 2016.
• [Cancer National Institut. Hematology : adverse effects of anti-cancer oral therapies] (french). Sept 2014.
• ATHOS team (french)
• [Cancer National Institut. oral anti-cancer therapy patients medical course : referral] (french). Nov 2016.
• [Cancer National Institut. Cancer Plan from 2003 to 2007] (french)
• [Cancer National Institut. Cancer Plan from 2009 to 2013] (french)
• [Cancer National Institut. Cancer Plan from 2014 to 2019] (french)

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018/01-CGT-GHMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No