PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments (PACOME)

With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care.

Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities.

The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care.

The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality).

This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Oncology; Oncoral Program
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine RIOUFOL, Pr; Phone Number: +33 04 78 86 43 68; Email: catherine.rioufol@chu-lyon.fr
• Study Contact Backup: Name: Anne-Gaëlle CAFFIN, Dr; Phone Number: +33 04 78 86 38 26; Email: anne-gaelle.caffin@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique
    • Contact: Catherine RIOUFOL, Pr
    • Sub-Investigator: Florence RANCHON, MCU-PH
    • Sub-Investigator: Anne-Gaëlle CAFFIN, Dr
    • Sub-Investigator: Marie-Anne CERFON, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients eligible for treatment with oral anticancer drugs (excluding clinical trials), followed at Lyon-Sud Hospital and benefiting from the ONCORAL programme.

Description

Inclusion Criteria:

• aged over 18
• eligible for treatment with oral anticancer drug (ATCO) (excluding clinical trial) in a cancer indication and whose treatment with an oral anticancer drug is scheduled
• follow-up in one of the following departments at Lyon-Sud hospital: pulmonology, dermatology, hematology, medical oncology, gastroenterology or radiotherapy.
• without a major psychiatric disorder likely to hinder the progress of the study, in the opinion of the investigator
• participant in the ONCORAL monitoring program
• Not having opposed participating in the study

Exclusion Criteria:

• in an institution
• under legal protection measure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oncoral patients; All adult patients with cancer, treated with oral anticancer drugs and benefiting of the ONCORAL program at the Lyon-Sud hospital	Other: Questionnaires; Patients will benefit of supervision by the ONCORAL team in the usual way and their intervention will be limited to completing questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative-Dose-Intensity (RDI) in real life with a prospective follow-up of 6 months within the limit of the duration of treatment with oral anticancer drugs by setting up a data platform for adult patients taking oral anticancer drugs	Value of RDI (Relative-Dose-Intensity) is the ratio between the dose prescribed to the patient versus the maximum reference dose recommended by the product characteristics summary of the drug. This ratio is expressed as a percentage (%).	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2037

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Real-life; Oral anticancer drugs; Cancer outpatient; Oncoral
• Additional Relevant MeSH Terms: Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 69HCL23_1237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No