CancerCHIMORALNCT01947296
Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
An observational study of Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 284 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jun 2016
- Phase
- Observational
- 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
Study population: Patients with oral antineoplastic agent introduction in the region of Ile-de-France
Who may be able to join
- patients affected by cancer (breast, colorectal, liver, lung, kidney, gastrointestinal stromal tumor, pancreas)
- treated by capecitabine, erlotinib, gefitinib, imatinib, lapatinib, sorafenib, sunitinib, vinorelbine, Evérolimus, Pazopanib, Etoposide, Topotécan
- 18 years old or more
Who cannot join
- refusal to participate
- lack proficiency in French ,
- having a Performance Status > 2,
- home based care,
- patient enrolled in clinical trials
- patient enrolled in therapeutic education program
- patient under administrative supervision or legal guardianship
- not affiliated with Patient Social Security or CMU (recipient or beneficiary)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.
Read the detailed description
Introduction :
Oral antineoplastic agents know a full development in particular targeted therapies. Their adverse events (AE) lately detected can lead to non compliance or treatment discontinuation which can be at the origin of disease progression. They can also lead to hospitalization or recourse to emergency department associating to cost for the society.
Hypothesis :
A coordinated intervention of cancer network in relation with primary healthcare professionals, would improve safety of care's patient treated with oral antineoplastic agent by preventing serious AEs through rapid detection.
Primary objective :
The primary objective is to estimate the effect of coordinated intervention of cancer network, in terms of number of early or unforeseen recourses to hospital for AE, within the first 6 months after oral neoplastic agent introduction.
Secondary objectives :
The secondary objective is to estimate the effect of coordinated intervention of cancer network, within the first 6 months after oral neoplastic agent introduction, in terms of number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, number of AE per detection grade, AE maximal grade, AE all grade, disease progression, the global survival (death for any causes and for AE), drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, quality of life, patient's satisfaction, medical economic evaluation
Primary outcome :
The main outcome is the number of early or unforeseen recourses to hospital for AE.
Secondary outcomes :
The secondary outcomes are all deaths and deaths from AE, number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, disease progression, drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, number of AE per detection grade, AE maximal grade, AE all grade, quality of life, patient's satisfaction, medical economic evaluationMethodology, design :
A comparative, controlled, not randomized, multicenter, prospective, "quasi-experimental" study, allows estimating evolution of patients according to the existence of a cancer network in their residence place.
Number of needed subjects: 440 patients.
Total duration of the study: 27 months. Inclusion Period: 21 months. length of participation period for one patient: 6 months. Number of participating centers: 21. Average number of inclusions a month by center: 4.
- Conditions
- Cancer
- Keywords
- Oral antineoplastic agent, Adverse Effects, Cancer Networks, Continuity of care, Coordination of patient's care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group " coordinated care" | Patient living in place covered by cancer network participating to the study is in the group "coordinated care" | |
| Group " usual care " | Patient living in place covered by cancer network non participating to the study or without cancer network is in the group "usual care" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of early or unforeseen recourses to hospital for adverse event.
Measured: within the first 6 monts after oral neoplastic agent introduction
Secondary outcomes (11)
all deaths and deaths from AE
Measured: within the first 6 monts after oral neoplastic agent introduction
number of hospitalization for AE
Measured: within the first 6 monts after oral neoplastic agent introduction
number of consultation for AE
Measured: within the first 6 monts after oral neoplastic agent introduction
number of early or unforeseen recourses to hospital for grade 1 / 2 AE
Measured: within the first 6 monts after oral neoplastic agent introduction
disease progression
Measured: within the first 6 monts after oral neoplastic agent introduction
drug dose-intensity taken by the patient during his treatment
Measured: within the first 6 monts after oral neoplastic agent introduction
number of recourses to the health care system
Measured: within the first 6 monts after oral neoplastic agent introduction
number of AE per detection grade, AE maximal grade, AE all grade
Measured: within the first 6 monts after oral neoplastic agent introduction
quality of life
Measured: within the first 6 monts after oral neoplastic agent introduction
patient's satisfaction
patient's satisfaction will be characterized with a questionnaire
Measured: within the first 6 monts after oral neoplastic agent introduction
medical economic evaluation
Medical economic evaluation use The incremental cost-effectiveness ratio (ICER. This is an equation used commonly in health economics to provide a practical approach to decision making regarding health interventions.
Measured: within the first 6 monts after oral neoplastic agent introduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- oncorif
- Responsible party
- Sponsor
- Investigators
- Jean-¨Pierre Lotz, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947296
- Sponsor's protocol ID
- NI 12019
- Other IDs
- C1204
- Acronym
- CHIMORAL
- Status last verified
- Feb 2017
- First submitted
- 2 Sep 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
- ClinicalTrials.gov ID
- NCT01947296
- Acronym / sponsor ID
- CHIMORAL / NI 12019
- Conditions
- Cancer
- Keywords
- Oral antineoplastic agent, Adverse Effects, Cancer Networks, Continuity of care, Coordination of patient's care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- oncorif
- Study start
- Oct 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Sep 2013 (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 purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.
Detailed description
Introduction :
Oral antineoplastic agents know a full development in particular targeted therapies. Their adverse events (AE) lately detected can lead to non compliance or treatment discontinuation which can be at the origin of disease progression. They can also lead to hospitalization or recourse to emergency department associating to cost for the society.
Hypothesis :
A coordinated intervention of cancer network in relation with primary healthcare professionals, would improve safety of care's patient treated with oral antineoplastic agent by preventing serious AEs through rapid detection.
Primary objective :
The primary objective is to estimate the effect of coordinated intervention of cancer network, in terms of number of early or unforeseen recourses to hospital for AE, within the first 6 months after oral neoplastic agent introduction.
Secondary objectives :
The secondary objective is to estimate the effect of coordinated intervention of cancer network, within the first 6 months after oral neoplastic agent introduction, in terms of number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, number of AE per detection grade, AE maximal grade, AE all grade, disease progression, the global survival (death for any causes and for AE), drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, quality of life, patient's satisfaction, medical economic evaluation
Primary outcome :
The main outcome is the number of early or unforeseen recourses to hospital for AE.
Secondary outcomes :
The secondary outcomes are all deaths and deaths from AE, number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, disease progression, drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, number of AE per detection grade, AE maximal grade, AE all grade, quality of life, patient's satisfaction, medical economic evaluationMethodology, design :
A comparative, controlled, not randomized, multicenter, prospective, "quasi-experimental" study, allows estimating evolution of patients according to the existence of a cancer network in their residence place.
Number of needed subjects: 440 patients.
Total duration of the study: 27 months. Inclusion Period: 21 months. length of participation period for one patient: 6 months. Number of participating centers: 21. Average number of inclusions a month by center: 4.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group " coordinated care" | – | –Patient living in place covered by cancer network participating to the study is in the group "coordinated care" |
| Group " usual care " | – | –Patient living in place covered by cancer network non participating to the study or without cancer network is in the group "usual care" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oral antineoplastic agent introduction in the region of Ile-de-France
Key inclusion criteria (3 listed)
- patients affected by cancer (breast, colorectal, liver, lung, kidney, gastrointestinal stromal tumor, pancreas)
- treated by capecitabine, erlotinib, gefitinib, imatinib, lapatinib, sorafenib, sunitinib, vinorelbine, Evérolimus, Pazopanib, Etoposide, Topotécan
- 18 years old or more
Key exclusion criteria (8 listed)
- refusal to participate
- lack proficiency in French ,
- having a Performance Status > 2,
- home based care,
- patient enrolled in clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of early or unforeseen recourses to hospital for adverse event.
Time frame: within the first 6 monts after oral neoplastic agent introduction
11 secondary outcomes
all deaths and deaths from AE
Time frame: within the first 6 monts after oral neoplastic agent introduction
number of hospitalization for AE
Time frame: within the first 6 monts after oral neoplastic agent introduction
number of consultation for AE
Time frame: within the first 6 monts after oral neoplastic agent introduction
number of early or unforeseen recourses to hospital for grade 1 / 2 AE
Time frame: within the first 6 monts after oral neoplastic agent introduction
disease progression
Time frame: within the first 6 monts after oral neoplastic agent introduction
drug dose-intensity taken by the patient during his treatment
Time frame: within the first 6 monts after oral neoplastic agent introduction
number of recourses to the health care system
Time frame: within the first 6 monts after oral neoplastic agent introduction
number of AE per detection grade, AE maximal grade, AE all grade
Time frame: within the first 6 monts after oral neoplastic agent introduction
quality of life
Time frame: within the first 6 monts after oral neoplastic agent introduction
patient's satisfaction
Time frame: within the first 6 monts after oral neoplastic agent introduction
medical economic evaluation
Time frame: within the first 6 monts after oral neoplastic agent introduction
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 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jean-¨Pierre Lotz, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Assistance Publique - Hôpitaux de Paris 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 8 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 23 Feb 2017. 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 early or unforeseen recourses to hospital for adverse event. (time frame: within the first 6 monts after oral neoplastic agent introduction). 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 23 Feb 2017.