Oncoral multidisciplinary monitoring for adults taking oral anticancer medicines
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
This project will test whether Oncoral's city–hospital monitoring and patient questionnaires help spot safety problems and improve care for adults taking oral anticancer drugs as outpatients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT06317389 on ClinicalTrials.gov |
What this trial studies
PACOME is an observational cohort of adult outpatients treated with oral anticancer drugs who are enrolled in the Oncoral multidisciplinary monitoring program at Lyon-Sud. Participants complete questionnaires while clinical and pharmacy teams collect real-life data on drug-related problems, dose changes, safety events, and healthcare use. The project analyzes predictive factors for medication-related problems and patterns of dose intensity and treatment modifications outside clinical trials. No experimental treatment is given—care is managed per usual practice within the Oncoral coordination model.
Who should consider this trial
Good fit: Adults (≥18) scheduled to receive an oral anticancer drug who are enrolled in the Oncoral monitoring program and followed in pulmonology, dermatology, hematology, medical oncology, gastroenterology, or radiotherapy at Lyon-Sud, without major psychiatric disorder and not opposed to participation.
Not a fit: Patients in interventional clinical trials, institutionalized patients, those under legal protection measures, or patients not followed in the specified Lyon-Sud departments are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this could reduce medication-related harms, help maintain appropriate dosing, and improve coordination of outpatient cancer care.
How similar studies have performed: Similar multidisciplinary outpatient medication‑monitoring programs, including the Oncoral initiative launched in 2014, have reported improved detection and management of drug-related problems, though large comparative outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pierre-Bénite
- Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Catherine RIOUFOL, Pr
- Email: catherine.rioufol@chu-lyon.fr
- Phone: 04 78 86 43 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.