CancerMinOSNCT03454971
Health Course of Patients Undergoing Per os Anti-cancer Therapy.
A study testing MinOS protocol in people with Cancer, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- MinOS protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2018to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Being tested
- MinOS protocol
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinOS protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MinOS arm | Experimental | Patients are followed according to MinOS protocol: Receives: Other: MinOS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- toxicity nature and grade according to CTCAE classification.
Measured: 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
Measured: 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
Measured: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
Number of unscheduled hospitalizations
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At the end of the 2nd cycle. One treatment cycle = 4 weeks, except for Sutent treatment : 1 cycle = 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start25 Apr 2018
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Mutualiste de Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454971
- Sponsor's protocol ID
- 2018/01-CGT-GHMG
- Acronym
- MinOS
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 8996131Noens 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.
PubMed 19349618Eliasson 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.
PubMed 21095002Compaci 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.
PubMed 21349519Compaci 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.
PubMed 26498342
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03454971
- Acronym / sponsor ID
- MinOS / 2018/01-CGT-GHMG
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Groupe Hospitalier Mutualiste de GrenobleUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MinOS arm | Experimental | Other: MinOS protocolPatients are followed according to MinOS protocol: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinOS protocolAt 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. | Other | MinOS arm |
Primary outcome
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)
12 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Background: PubMed 8996131Liu 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.
- Background: PubMed 19349618Noens 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.
- Background: PubMed 21095002Eliasson 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.
- Background: PubMed 21349519Compaci 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.
- Background: PubMed 26498342Compaci 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.
- \[Cancer National Institut. Plan Cancer 2014-2019\] (French). Febr 2015.Link provided by the sponsor.
- \[Oncorif. White book : Organisation and care of patient undergoing oral targeted therapy in hematology\] (french). Nov 2016.Link provided by the sponsor.
- \[Cancer National Institut. Hematology : adverse effects of anti-cancer oral therapies\] (french). Sept 2014.Link provided by the sponsor.
- \[APM. Oral chemotherapies : nurses' part and role\] (french). July 2014.Link provided by the sponsor.
- ATHOS team (french)Link provided by the sponsor.
- \[Cancer National Institut. oral anti-cancer therapy patients medical course : referral\] (french). Nov 2016.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MinOS protocol in people with Cancer, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454971, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.