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

NCT06317389 | Recruiting

• 1 other identifier: 69HCL23_1237
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Oncology; Oncoral Program

Keywords

Cancer outpatient; Oral anticancer drugs; Oncoral; Real-life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Questionnaires OTHER

Patients will benefit of supervision by the ONCORAL team in the usual way and their intervention will be limited to completing questionnaires.

Oncoral patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• in an institution
• under legal protection measure

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Catherine RIOUFOL, Pr

CONTACT

04 78 86 43 68; catherine.rioufol@chu-lyon.fr

Anne-Gaëlle CAFFIN, Dr

CONTACT

04 78 86 38 26; anne-gaelle.caffin@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: June 23, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2037
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

FR (1)