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

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

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France
        • AP-HP Hôpital européen Georges-Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Historic cohort
Retrospective cohort of patients that were treated in the Hôpital Européen Georges Pompidou before the creation of the care pathway unit.
Prospective cohort
All consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start.
Patients from the prospective cohort will have their health care scheduled by the care pathway unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time between the first appointment with the oncologist and the beginning of antitumoral treatment.
Time Frame: 6 months
Delay of health care
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients satisfaction
Time Frame: 6 months
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.
6 months
Health care teams satisfaction
Time Frame: 6 months
Satisfaction of health care teams : qualitative questionnaire with 4 ordered modalities (very satisfied to not satisfied)
6 months
Rate of emergency consultations and hospitalizations
Time Frame: 6 months
Need for unexpected health care
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Virginie Bichon, AP-HP, Hôpital Européen Georges Pompidou, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

one year after the last publication

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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