CancerPARCOURSNCT03561467
Oral Chemotherapy and Quality of Care
An observational study of Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
PARCOURS is a non-interventional research study evaluating dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy (60 patients followed for 3 months). References used are the National Cancer Institute recommendations for the oral chemotherapy treated outpatients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Observational
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2018to 29 Sep 2018
- 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: Adult outpatients treated by oral chemotherapy for a cancer disease
Who may be able to join
- Patient over 18 years old
- Suffering from cancer (hematological malignancies, digestive tumors, thoracic tumors or cutaneous tumors)
- With an oral anticancer chemotherapy initial prescription written by an oncologist or hematologist from the University Hospital of Caen, whatever the place of the drug dispensing (Community pharmacy or hospital pharmacy )
Who cannot join
- Patient treated by oral anticancer chemotherapy for another pathology
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hopsital
Caen
Valérie Chedru-Legros, PhD
About this study
Official title: Community and Hospital Experiences for Patients Treated by Oral Chemotherapy at the University Hospital of Caen: Analysis of the Process and Its Dysfunctions
PARCOURS is a non-interventional research study evaluating dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy (60 patients followed for 3 months).
References used are the National Cancer Institute recommendations for the oral chemotherapy treated outpatients.
Parameters found are : information exchanged, ambulatory and hospital monitoring in case of adverse event and adherence to treatment. The study includes also a medico-economic evaluation (hospitalization and transport spending in case of dysfunction in the patient's journey). Deviations will be analyzed.
- Conditions
- Cancer
- Being tested
- Observational
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Evaluation of dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dysfunctions
Number of dysfunctions objectified during the 3-month follow-up period, by sub-processes of the course
Measured: 3 months
Secondary outcomes (8)
Drug adherence
measured by Morisky-Green's questionnaire to the patient
Measured: 3 months
Drug adherence
measured by Data on the refill of prescriptions with the National Health Insurance, and evaluated according to the Drug Possession Ratio
Measured: 3 months
Adverse events
number
Measured: 3 months
Expenses related to the use of unplanned hospital care
Expenses related to the use of unplanned hospital care during the follow-up period: number of oncologist consultations, transport spending, emergency rehospitalizations and additional examinations.
Measured: 3 months
Satisfaction of the patient
RESOCAN questionnaire
Measured: At month 3
Satisfaction of the caregiver
RESOCAN questionnaire
Measured: At month 3
Satisfaction of the local professionals
RESOCAN questionnaire
Measured: At month 3
Quality of life of patients
QLQC 30
Measured: At month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start29 Mar 2018
- Primary completion29 Jun 2018 (estimated)
- Study completion29 Sep 2018 (estimated)
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 University Hospital, CaenThe 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- MSD France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561467
- Sponsor's protocol ID
- 17-134
- Acronym
- PARCOURS
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community and Hospital Experiences for Patients Treated by Oral Chemotherapy at the University Hospital of Caen: Analysis of the Process and Its Dysfunctions
- ClinicalTrials.gov ID
- NCT03561467
- Acronym / sponsor ID
- PARCOURS / 17-134
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- MSD France
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 29 Jun 2018 (estimated)
- Study completion
- 29 Sep 2018 (estimated)
- First posted
- 19 Jun 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.
PARCOURS is a non-interventional research study evaluating dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy (60 patients followed for 3 months).
References used are the National Cancer Institute recommendations for the oral chemotherapy treated outpatients.
Parameters found are : information exchanged, ambulatory and hospital monitoring in case of adverse event and adherence to treatment. The study includes also a medico-economic evaluation (hospitalization and transport spending in case of dysfunction in the patient's journey). Deviations will be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients treated by oral chemotherapy for a cancer disease
Key inclusion criteria (3 listed)
- Patient over 18 years old
- Suffering from cancer (hematological malignancies, digestive tumors, thoracic tumors or cutaneous tumors)
- With an oral anticancer chemotherapy initial prescription written by an oncologist or hematologist from the University Hospital of Caen, whatever the place of the drug dispensing (Community pharmacy or hospital pharmacy )
Key exclusion criteria (1 listed)
- Patient treated by oral anticancer chemotherapy for another pathology
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 |
|---|---|---|
| ObservationalEvaluation of dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy | Other | – |
Primary outcome
Number of dysfunctions
Time frame: 3 months
Number of dysfunctions objectified during the 3-month follow-up period, by sub-processes of the course
8 secondary outcomes
Drug adherence
Time frame: 3 months
Drug adherence
Time frame: 3 months
Adverse events
Time frame: 3 months
Expenses related to the use of unplanned hospital care
Time frame: 3 months
Satisfaction of the patient
Time frame: At month 3
Satisfaction of the caregiver
Time frame: At month 3
Satisfaction of the local professionals
Time frame: At month 3
Quality of life of patients
Time frame: At month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
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 University Hospital, Caen 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 1 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 19 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie CHEDRU-LEGROS, PhD (+332 31 06 46 66, chedru-v@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dysfunctions (time frame: 3 months). 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 19 Jun 2018.