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

NCT03454971 | Completed

• 1 other identifier: 2018/01-CGT-GHMG
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Toxicity evaluation of targeted oral therapies

  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

  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

Study Arms (1)

MinOS arm

EXPERIMENTAL

Patients are followed according to MinOS protocol:

Other: MinOS protocol

Interventions

MinOS protocol 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.

MinOS arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ECOG performance score \< 2
• Patient already included in an interventional clinical research protocol

Sponsors & Collaborators

• Groupe Hospitalier Mutualiste de Grenoble: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

Related Publications (5)

• 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.

  PMID: 8996131 BACKGROUND

• 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.

  PMID: 19349618 BACKGROUND

• 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.

  PMID: 21095002 BACKGROUND

• 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.

  PMID: 21349519 BACKGROUND

• 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.

  PMID: 26498342 BACKGROUND

Related 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.
• \[APM. Oral chemotherapies : nurses' part and role\] (french). July 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)

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 6, 2018
• Study Start: April 25, 2018
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)