Integrated Care Pathway in Oncology (PASSION)

Breast Cancer Clinical Trial

— PASSION  

Official title:

Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04235556
• Other study ID #: APHP190973
• Status: Active, not recruiting
• Start date: February 21, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Colon Cancer
• Gastric Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Thoracic Neoplasms

Intervention

Behavioral:
• Care pathway unit
Patients from the prospective cohort will have their health care scheduled by the care pathway unit.

Locations

Country	Name	City	State
France	AP-HP Hôpital européen Georges-Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	MSD France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between the first appointment with the oncologist and the beginning of antitumoral treatment.	Delay of health care	6 months
Secondary	Patients satisfaction	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
Secondary	Health care teams satisfaction	Satisfaction of health care teams : qualitative questionnaire with 4 ordered modalities (very satisfied to not satisfied)	6 months
Secondary	Rate of emergency consultations and hospitalizations	Need for unexpected health care	6 months