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Completed

NCT Number: NCT03454971

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

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Number of patients that followed the entirety of MinOS follow-up.

    Time frame: At the eighth follow-up, which is 8 weeks from baseline, except for Sutent treatment (12 weeks from baseline)

    • 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)

Secondary outcomes

  1. Toxicity evaluation of targeted oral therapies

    Time frame: 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

    • toxicity nature and grade according to CTCAE classification.

  2. Evaluation of observance

    Time frame: End of the 1st and 2nd treatment cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

    • Observance score of Morisky

  3. Number of unscheduled phone calls

    Time frame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

  4. Number of unscheduled hospitalizations

    Time frame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

  5. Number of private healthcare professionals visit

    Time frame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

  6. Number of private healthcare professionals' phone call to the hospital

    Time frame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

  7. Description of the exchange of information between the hospital and independent health professionals

    Time frame: Day 1 of the 1st and 2nd treatment cycles. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

    • 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)

  8. Description of the patient's independence in regard of his treatment and pathology

    Time frame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

    • Number of patient's phone call to the hospital

  9. Evaluation of patient's satisfaction in regard of MinOS protocol

    Time frame: 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

    • Satisfaction survey answered by patients

  10. Evaluation of private healthcare professionals' satisfaction in regard of MinOS protocol

    Time frame: 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

    • Satisfaction survey answered by private healthcare professionals

  11. Evaluation of the quality of life for patients recruited in MinOS protocol

    Time frame: Day 1 of 1st, 2nd and 3rd cycle of treatment. One treatment cycle = 4 weeks, except for Sutent treatment: 1 cycle = 6 weeks

    • Score of QLQ-C30 questionnaire

  12. Number of concomitant drug prescription modification by the hospital pharmacist due to drug interactions with the cancer treatment

    Time frame: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks

    • 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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Mutualiste de Grenoble

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Official study 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.

Acronym: MinOS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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