Integrated Care Pathway in Oncology (PASSION)

• Conditions: Bladder Cancer; Colon Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer; Gastric Cancer; Thoracic Neoplasms; Breast Cancer
• Interventions: Behavioral: Care pathway unit

• Registration Number: NCT04235556
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Study Start: 2020-02-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Care pathway unit	All consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start.

Primary Outcome Measures

Name	Time	Method
Time between the first appointment with the oncologist and the beginning of antitumoral treatment.	6 months	Delay of health care

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AP-HP Hôpital européen Georges-Pompidou; 🇫🇷 Paris, France