- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235556
Integrated Care Pathway in Oncology (PASSION) (PASSION)
Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers
A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).
The aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.
The second aim is to assess the satisfaction of patients and health care teams.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PASSION is a french monocentric study.
For the retrospective cohort, patient will be selected through the use of data warehouse available on the HEGP.
For the prospective cohort, patient will be included according to the selection criteria.
Each patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy.
For both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the HEGP.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Paris, France
- AP-HP Hôpital européen Georges-Pompidou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Retrospective cohort: patients treated at the Hôpital Européen Georges Pompidou in 2015 and 2017.
Prospective cohort:
- Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer
- First appointment for cancer care at the Hôpital Européen Georges Pompidou
- Ile de France resident
- All appointments planned at the Hôpital Européen Georges Pompidou
- Intravenous antitumoral treatment
Description
Inclusion Criteria:
- Histologically proven : colon, gastric, pancreatic, prostate, bladder, breast, thoracic, or ovarian cancer
- First appointment for cancer care at the Hôpital Européen Georges Pompidou
- Intravenous antitumoral treatment
Exclusion Criteria:
- Medical care non covered by social welfare
- Radiochemotherapy
- Death in the 6 months following first oncological appointment or absence of medical care in the year following the first oncological appointment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Historic cohort
Retrospective cohort of patients that were treated in the Hôpital Européen Georges Pompidou before the creation of the care pathway unit.
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Prospective cohort
All consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start.
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Patients from the prospective cohort will have their health care scheduled by the care pathway unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time between the first appointment with the oncologist and the beginning of antitumoral treatment.
Time Frame: 6 months
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Delay of health care
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients satisfaction
Time Frame: 6 months
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Satisfaction of patients with OUT-PATSAT35 questionnaire (out-patient satisfaction) : Likert type scale with 5 ordered modalities (bad to excellent), rated from 1 to 5.
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6 months
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Health care teams satisfaction
Time Frame: 6 months
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Satisfaction of health care teams : qualitative questionnaire with 4 ordered modalities (very satisfied to not satisfied)
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6 months
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Rate of emergency consultations and hospitalizations
Time Frame: 6 months
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Need for unexpected health care
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6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Virginie Bichon, AP-HP, Hôpital Européen Georges Pompidou, Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP190973
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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