Integrated Care Pathway in Oncology (PASSION)

NCT04235556 | Unknown

• 1 other identifier: APHP190973
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

care pathway; satisfaction; oncology; treatment delay

Outcome Measures

Primary Outcomes (1)

• Time between the first appointment with the oncologist and the beginning of antitumoral treatment.

  Delay of health care

  6 months

Secondary Outcomes (3)

• Patients satisfaction

  6 months

• Health care teams satisfaction

  6 months

• Rate of emergency consultations and hospitalizations

  6 months

Study Arms (2)

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.

Behavioral: Care pathway unit

Interventions

Care pathway unit BEHAVIORAL

Patients from the prospective cohort will have their health care scheduled by the care pathway unit.

Prospective cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• MSD France: collaborator

Study Sites (1)

AP-HP Hôpital européen Georges-Pompidou

Paris, France

Location

MeSH Terms

Conditions

Colonic Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Thoracic Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Personal Satisfaction; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Behavior

Study Officials

• Virginie Bichon

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 22, 2020
• Study Start: February 21, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: one year after the last publication
• 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

Locations

FR (1)