Metastatic Renal Cell CarcinomaPRISM careNCT02849535
Impact of the PRISM-care Multidisciplinary Oncology Program on Secured Drug Intake of Patients With Kidney Cancer
A study testing PRISM care program in people with Metastatic Renal Cell Carcinoma, run by Hospices Civils de Lyon at 12 sites in France.
Trial summary
The rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- PRISM care program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 12 sitesFrance
- Study dates
- 17 Oct 2017to Apr 2023
- 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 aged 18 years old or more
- With metastatic renal cell carcinoma
- With an initiation or change of oral targeted therapy, especially: tyrosine kinase inhibitor (sunitinib, sorafenib, pazopanib, axitinib) or mTor inhibitor (everolimus)
- With ambulatory status (not hospitalized for the management and treatment of its metastatic renal cell carcinoma)
- Without either cognitive disorders or major psychiatric disorders
- With a sufficient autonomy for the management of medication at home
Show all 9Show fewer
- Having declared an outpatient doctor
- Having declared a usual pharmacy
- Having given his written consent to participate in the study
Who cannot join
- Significant cognitive and psychiatric disorders
- Management of medication at home exclusively performed by the family caregiver
- Patient in an institution or under guardianship, major protected by law
- Patient refusing to participate in the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers
Remy DELVA
- Recruiting
CH de Chambéry
Chambéry
Mélanie TADJ LESAGE
- Recruiting
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand
Hakim MAHAMMEDI
- Recruiting
Centre Léon Bérard
Lyon
Helen BOYLE
- Recruiting
Hôpital Arnaud de Villeneuve
Montpellier
Clothilde LINDET -BOURGEOIS
- Recruiting
APHP Hôpital de la Pitié Salpétrière
Paris
Haide BOOSTAN
- Recruiting
Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet
Pierre-Bénite, 69495
Catherine RIOUFOL, PharmD, (0)4 78 86 43 70 ext. +33, catherine.rioufol@chu-lyon.fr
Soumia BAYARASSOU, (0)4 72 11 51 69 ext. +33, soumia.bayarassou01@chu-lyon.fr
- Recruiting
Institut Jean Godinot de Reims
Reims
Jean-Christophe EYMARD
- Recruiting
CHU
Rouen
Fréderic DI FIORE
- Recruiting
ICL Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez
Aline GUILLOT
- Recruiting
Hôpital Bretonneau
Tours
Claude LINASSIER
- Recruiting
CH Lacari
Vichy
Souad SALHI
About this study
Official title: Impact of the PRISM-care Multidisciplinary Oncology Program Versus Usual Care on Secured Drug Intake of Patients With Kidney Cancer, Through Self-management of Adverse Events Related to Oral Targeted Therapies, Control of Drug Interactions, and Sharing of the Information Between Ambulatory and Hospital Settings.
The rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the more important that ambulatory monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.
Adverse drug reactions are a major concern, as such, and because they involve prescription changes (dose reduction, treatment interruption). This results in a decrease in the dose taken and a risk of loss of efficacy.
Read more
In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher because the oral targeted therapies available in this indication have a safety profile marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce the treatment adherence (digestive and skin toxicities). In addition, these molecules are metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss of efficacy.
The investigators propose to assess a program set up to secure drug taking by enhancing self-management of side effects and control of drug interactions by the patient. This program includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent pharmacist and liberal nurse) professionals.
The hypothesis of the study is that the PRISM care program will improve self-management of side effects by the patient, resulting in a relative dose intensity of oral chemotherapy improved compared to usual care.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- PRISM care program
- Keywords
- Oral chemotherapy, Relative dose intensity, Health related program, Secured drug intake
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISM care programBehavioural
PRISM care is a multidisciplinary program that includes sessions with a hospital pharmacist about the oral chemotherapy: information is given to the patient on adverse events occurrence and management, optimizing drug dosage plan, including drug-drug interactions. Physical sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion, then telephone interviews of physical sessions will be planned at month 4, month 5 and month 6. During all these sessions and during the final physical session at the end of month 6, data will be recorded for outcomes assessment.
| Study group | Role | What they receive |
|---|---|---|
| PRISM care program | Experimental | PRISM care is a multidisciplinary program that includes sessions with a hospital pharmacist about the oral chemotherapy: information is given to the patient on adverse events occurrence and management, optimizing drug dosage plan, including drug-drug interactions. Physical sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion, then telephone interviews of physical sessions will be planned at month 4, month 5 and month 6. During all these sessions and during the final physical session at the end of month 6, data will be recorded for outcomes assessment. Receives: Behavioral: PRISM care program |
| Standard of care | No intervention | In the group with standard of care, patients will have interviews with a hospital pharmacist only dedicated to the record of data for outcomes assessment. These sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion , and at the end at month 6 after the final physical session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative dose intensity of oral chemotherapy
Relative dose intensity will be computed by the ratio between the overall dose delivered and the overall dose prescribed during the 6 months of follow-up.
Measured: 6 months from the treatment initiation
Secondary outcomes (19)
Adherence to the oral chemotherapy measured with the prescription renewal rate
Adherence will be measured with the prescription renewal rate by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).
Measured: 6 months from the treatment initiation
Adherence to the oral chemotherapy measured with the Girerd questionnaire
the Girerd questionnaire is a medication adherence questionnaire
Measured: 6 months from the treatment initiation
Grade 3 and 4 adverse events related to the oral chemotherapy
Measured: 6 months from the treatment initiation
Drug interactions (for patients included in the interventional group)
Measured: 6 months from the treatment initiation
Cause of changes dose relative intensity: number of reduction of dosage
Measured: 6 months from the treatment initiation
Cause of changes dose relative intensity: number of interruption or discontinuation of treatment
Measured: 6 months from the treatment initiation
Number of unplanned hospitalizations related to the oral chemotherapy
Measured: 6 months from the treatment initiation
Number of emergency admissions related to the oral chemotherapy
Measured: 6 months from the treatment initiation
Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists
Measured: 6 months from the treatment initiation
Consumption of health care resources: number of acts of biology
Measured: 6 months from the treatment initiation
Consumption of health care resources: number of acts of imagery
Measured: 6 months from the treatment initiation
Consumption of health care resources: number of prescribed drugs and self-medication and other health products
Measured: 6 months from the treatment initiation
Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0)
Measured: Inclusion and 6 months from the treatment initiation
Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire
Measured: Inclusion and 6 months from the treatment initiation
Rate of patients presenting satisfying knowledge about adverse effects of their oral chemotherapy, according to the hospital pharmacists and measured with a 4-items Likert scale
Measured: 2 months and 6 months from the treatment initiation
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Measured: Inclusion and 6 months from the treatment initiation
Patient's perception of its illness, measured with the Brief Illness Perception Questionnaire (B-IPQ)
Measured: Inclusion and 6 months from the treatment initiation
Involvement of outpatient caregivers (doctors, pharmacists and liberal nurses) in the PRISM care program
Involvement will be described by the number and type of: interventions recorded on a dedicated form, solicitations of hospital staff, treatment modifications realized in concertation between oncologist and outpatient doctor.
Measured: During the 6 months of follow-up
Satisfaction of outpatient caregivers (doctors, pharmacists and liberal nurses) relative to the PRISM care program, measured with a rating out of 10
Measured: 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start17 Oct 2017
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine RIOUFOL, PharmD PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849535
- Sponsor's protocol ID
- 69HCL14_0453
- Acronym
- PRISM care
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the PRISM-care Multidisciplinary Oncology Program Versus Usual Care on Secured Drug Intake of Patients With Kidney Cancer, Through Self-management of Adverse Events Related to Oral Targeted Therapies, Control of Drug Interactions, and Sharing of the Information Between Ambulatory and Hospital Settings.
- ClinicalTrials.gov ID
- NCT02849535
- Acronym / sponsor ID
- PRISM care / 69HCL14_0453
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Oral chemotherapy, Relative dose intensity, Health related program, Secured drug intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- 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.
The rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the more important that ambulatory monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.
Adverse drug reactions are a major concern, as such, and because they involve prescription changes (dose reduction, treatment interruption). This results in a decrease in the dose taken and a risk of loss of efficacy.
In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher because the oral targeted therapies available in this indication have a safety profile marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce the treatment adherence (digestive and skin toxicities). In addition, these molecules are metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss of efficacy.
The investigators propose to assess a program set up to secure drug taking by enhancing self-management of side effects and control of drug interactions by the patient. This program includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent pharmacist and liberal nurse) professionals.
The hypothesis of the study is that the PRISM care program will improve self-management of side effects by the patient, resulting in a relative dose intensity of oral chemotherapy improved compared to usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM care program | Experimental | Behavioral: PRISM care programPRISM care is a multidisciplinary program that includes sessions with a hospital pharmacist about the oral chemotherapy: information is given to the patient on adverse events occurrence and management, optimizing drug dosage plan, including drug-drug interactions. Physical sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion, then telephone interviews of physical sessions will be planned at month 4, month 5 and month 6. During all these sessions and during the final physical session at the end of month 6, data will be recorded for outcomes assessment. |
| Standard of care | No intervention | –In the group with standard of care, patients will have interviews with a hospital pharmacist only dedicated to the record of data for outcomes assessment. These sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion , and at the end at month 6 after the final physical session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient aged 18 years old or more
- With metastatic renal cell carcinoma
- With an initiation or change of oral targeted therapy, especially: tyrosine kinase inhibitor (sunitinib, sorafenib, pazopanib, axitinib) or mTor inhibitor (everolimus)
- With ambulatory status (not hospitalized for the management and treatment of its metastatic renal cell carcinoma)
- Without either cognitive disorders or major psychiatric disorders
Key exclusion criteria (4 listed)
- Significant cognitive and psychiatric disorders
- Management of medication at home exclusively performed by the family caregiver
- Patient in an institution or under guardianship, major protected by law
- Patient refusing to participate in the study
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 |
|---|---|---|
| PRISM care programPRISM care is a multidisciplinary program that includes sessions with a hospital pharmacist about the oral chemotherapy: information is given to the patient on adverse events occurrence and management, optimizing drug dosage plan, including drug-drug interactions. Physical sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion, then telephone interviews of physical sessions will be planned at month 4, month 5 and month 6. During all these sessions and during the final physical session at the end of month 6, data will be recorded for outcomes assessment. | Behavioural | PRISM care program |
Primary outcome
Relative dose intensity of oral chemotherapy
Time frame: 6 months from the treatment initiation
Relative dose intensity will be computed by the ratio between the overall dose delivered and the overall dose prescribed during the 6 months of follow-up.
19 secondary outcomes
Adherence to the oral chemotherapy measured with the prescription renewal rate
Time frame: 6 months from the treatment initiation
Adherence to the oral chemotherapy measured with the Girerd questionnaire
Time frame: 6 months from the treatment initiation
Grade 3 and 4 adverse events related to the oral chemotherapy
Time frame: 6 months from the treatment initiation
Drug interactions (for patients included in the interventional group)
Time frame: 6 months from the treatment initiation
Cause of changes dose relative intensity: number of reduction of dosage
Time frame: 6 months from the treatment initiation
Cause of changes dose relative intensity: number of interruption or discontinuation of treatment
Time frame: 6 months from the treatment initiation
Number of unplanned hospitalizations related to the oral chemotherapy
Time frame: 6 months from the treatment initiation
Number of emergency admissions related to the oral chemotherapy
Time frame: 6 months from the treatment initiation
Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists
Time frame: 6 months from the treatment initiation
Consumption of health care resources: number of acts of biology
Time frame: 6 months from the treatment initiation
Consumption of health care resources: number of acts of imagery
Time frame: 6 months from the treatment initiation
Consumption of health care resources: number of prescribed drugs and self-medication and other health products
Time frame: 6 months from the treatment initiation
Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0)
Time frame: Inclusion and 6 months from the treatment initiation
Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire
Time frame: Inclusion and 6 months from the treatment initiation
Rate of patients presenting satisfying knowledge about adverse effects of their oral chemotherapy, according to the hospital pharmacists and measured with a 4-items Likert scale
Time frame: 2 months and 6 months from the treatment initiation
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Time frame: Inclusion and 6 months from the treatment initiation
Patient's perception of its illness, measured with the Brief Illness Perception Questionnaire (B-IPQ)
Time frame: Inclusion and 6 months from the treatment initiation
Involvement of outpatient caregivers (doctors, pharmacists and liberal nurses) in the PRISM care program
Time frame: During the 6 months of follow-up
Satisfaction of outpatient caregivers (doctors, pharmacists and liberal nurses) relative to the PRISM care program, measured with a rating out of 10
Time frame: 6 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Catherine RIOUFOL, PharmD PhD principal investigator
Hospices Civils de Lyon
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM care program in people with Metastatic Renal Cell Carcinoma, run by Hospices Civils de Lyon at 12 sites 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine RIOUFOL, PharmD PhD ((0)4 78 86 43 70 ext. +33, catherine.rioufol@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative dose intensity of oral chemotherapy (time frame: 6 months from the treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.