Clinical trial NCT04235556: Integrated Care Pathway in Oncology (PASSION)
Official title: Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Gastric Cancer
Pancreatic Cancer
Thoracic Neoplasms
Breast Cancer
Ovarian Cancer
Bladder Cancer
Prostate Cancer
Keywords: care pathway
satisfaction
oncology
treatment delay
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: MSD France
First posted: 2020-01-22
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time between the first appointment with the oncologist and the beginning of antitumoral treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Patients satisfaction
timeFrame: 6 months
measure: Health care teams satisfaction
timeFrame: 6 months
measure: Rate of emergency consultations and hospitalizations
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Hôpital européen Georges-Pompidou
Study officials:
affiliation: AP-HP, Hôpital Européen Georges Pompidou, Paris
name: Virginie Bichon
role: PRINCIPAL_INVESTIGATOR
References: