Treatment Related CancerNCT03293966
A Coordination Card of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization
An observational study of Treatment Related Cancer, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.This takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Related Cancer
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 31 Dec 2017
- How long will I take part?
- 1 Day
- 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: All patients admitted to thoracic pneumology and oncology treated with anticancer drugs will receive a medication conciliation. Patients integrating the study will be patients who have benefited from the entire process of medication conciliation (entry and exit) and returning home. The included patients must have attended the same pharmacy for at least 3 months (according to the patient declaration).
Who may be able to join
- all patient admitted in onco-thoracic service
- Handled by an anticancer agent
- Having frequented the same city pharmacy for at least 3 months
Who cannot join
- hospitalization above 21 days
- refusing participation
- palliative care
- misunderstanding of french language
- frequenting several pharmacy
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Therapeutic CARE of the Bronchial Cancer Not in Small Cell: Security of the Dispensation of Medicine by the Implementation of a Card of Coordination of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization
The continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.This takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. This is clearly the case of cancer coverage.
The optimization of the therapeutic suppor in town is based on pharmaceutical advice strengthening but also on the pharmaceutical analysis to check the entire treatments' prescription and eventual medicinal interactions which ensue from it.That's why it's important to have a medicinal conciliation that takes into account all the medecine taken or have to be taken by the patient.
Read more
A specific support was developped by nurses , doctors and pharmacist ; it's a care coordination card that can be put easely in a pocket by the patient.
The aim of the study is that this card can be also used as a communication tools by sharing the prescription done at the release of hospital by using an IT link (flea datamatrix) for the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is complex in term of extra hospital coverage.
Read the detailed description
The aim of this strudy is to evaluate with community pharmacists the impact of a new information system on the prevalence of dispensing difficulties reported by pharmacies when hospitalized patients leave the city. This information system will be based on the care coordination card implemented by a secure computer link allowing the use of information on treatments prescribed at the end of hospitalization. Patient management is not changed by this protocol. Only the information of the pharmacist, which is the object of the study, is increased.
- Conditions
- Treatment Related Cancer
- Medical subject headings
- Neoplasms, Second Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criteria including all the dysfunctions noticed at the release of the hospital prescription intended to be dispensed in town.
Measured: 7days+/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jun 2016
- Primary completion28 Feb 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Related 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293966
- Sponsor's protocol ID
- PRIMACIE
- Status last verified
- May 2018
- First submitted
- 21 Sep 2017
- Last updated
- 1 Jun 2018
- 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 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic CARE of the Bronchial Cancer Not in Small Cell: Security of the Dispensation of Medicine by the Implementation of a Card of Coordination of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization
- ClinicalTrials.gov ID
- NCT03293966
- Acronym / sponsor ID
- PRIMACIE
- Conditions
- Treatment Related Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Sep 2017 (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.
The continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.This takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. This is clearly the case of cancer coverage.
The optimization of the therapeutic suppor in town is based on pharmaceutical advice strengthening but also on the pharmaceutical analysis to check the entire treatments' prescription and eventual medicinal interactions which ensue from it.That's why it's important to have a medicinal conciliation that takes into account all the medecine taken or have to be taken by the patient.
A specific support was developped by nurses , doctors and pharmacist ; it's a care coordination card that can be put easely in a pocket by the patient.
The aim of the study is that this card can be also used as a communication tools by sharing the prescription done at the release of hospital by using an IT link (flea datamatrix) for the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is complex in term of extra hospital coverage.
Detailed description
The aim of this strudy is to evaluate with community pharmacists the impact of a new information system on the prevalence of dispensing difficulties reported by pharmacies when hospitalized patients leave the city. This information system will be based on the care coordination card implemented by a secure computer link allowing the use of information on treatments prescribed at the end of hospitalization. Patient management is not changed by this protocol. Only the information of the pharmacist, which is the object of the study, is increased.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to thoracic pneumology and oncology treated with anticancer drugs will receive a medication conciliation. Patients integrating the study will be patients who have benefited from the entire process of medication conciliation (entry and exit) and returning home. The included patients must have attended the same pharmacy for at least 3 months (according to the patient declaration).
Key inclusion criteria (3 listed)
- all patient admitted in onco-thoracic service
- Handled by an anticancer agent
- Having frequented the same city pharmacy for at least 3 months
Key exclusion criteria (5 listed)
- hospitalization above 21 days
- refusing participation
- palliative care
- misunderstanding of french language
- frequenting several pharmacy
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
Composite criteria including all the dysfunctions noticed at the release of the hospital prescription intended to be dispensed in town.
Time frame: 7days+/- 2 days
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 1 Jun 2018.
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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?
An observational study of Treatment Related Cancer, run by Fondation Hôpital Saint-Joseph 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 5 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 1 Jun 2018. 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?
Composite criteria including all the dysfunctions noticed at the release of the hospital prescription intended to be dispensed in town. (time frame: 7days+/- 2 days). 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 1 Jun 2018.