Evaluation of the ONCORAL Program for Patients on Oral Cancer Drugs

Medico-economic Evaluation of the ONCORAL Program of Multidisciplinary ONCOlogic Interventions Between Town and Hospital (Doctor-pharmacist-nurse) for Ambulatory Patients Under oRAL Anticancer Drugs Versus Usual Care

This study is testing a program that helps cancer patients taking oral medications to see if it can lower their treatment costs and improve their overall care compared to regular treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 215 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Pierre-Bénite)
• Trial ID: NCT03660670 on ClinicalTrials.gov

What this trial studies

This study evaluates the economic impact of the ONCORAL program designed for ambulatory cancer patients receiving oral anticancer drugs compared to usual care. It aims to address the challenges associated with the increasing costs of cancer treatments and the management of adverse drug effects. The program focuses on therapeutic education to improve patient adherence and reduce hospitalizations due to complications from oral chemotherapy. By analyzing the effectiveness and economic implications of this approach, the study seeks to enhance patient autonomy and optimize healthcare resources.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are cancer patients prescribed oral anticancer drugs and considered at risk for drug-related issues.

Not a fit: Patients without significant risk factors for drug interactions or those who are not prescribed oral anticancer medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could improve patient outcomes and reduce healthcare costs associated with oral anticancer treatments.

How similar studies have performed: Other studies have shown promising results with similar programs aimed at improving the management of oral chemotherapy, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Adult more than 18 years-old
* Cancer patient
* For whom an initiation or a change of oral anticancer is prescribed according to the AMM
* Considered by the oncologist as at iatrogenic drug risk, or having 3 or more risk factors, to develop an iatrogenic drug issue among the following risk factors:
* ≥ 2 oral anticancer drugs,
* ≥ 2 lines of treatment,
* combination with an injectable chemotherapy,
* rhythm discontinuous intake of oral anticancer,
* ≥ 2 associated chronic conditions,
* number of associated drugs including oral anticancer ≥5,
* creatinine clearance \<60 ml / min,
* frailties and psychosocial conditions at risk (isolated patient, foreign, having limited autonomy)
* without major psychiatric cognitive impairment that may interfere with the ONCORAL program;
* in sufficient autonomy to manage his home treatment;
* signed a written informed consent to participate;
* Affiliate or beneficiary of a Social Security or similar.

Exclusion Criteria:

* Treated with oral anticancer in a clinical trial or temporal use authorization
* Management of oral anticancer treatment exclusively by the caregiver;
* Who did not report a regular physician or pharmacy, or who reported ≥2 or more regular street pharmacies;
* In an institution or guardianship, a major protected by the law;
* Participation in a clinical trial that may alter the costs of care.

Where this trial is running

Pierre-Bénite

• Centre Hospitalier Lyon Sud — Pierre-Bénite, France (RECRUITING)

Study contacts

• Principal investigator: Catherine RIOUFOL, PharmD — Hospices Civils de Lyon
• Study coordinator: Catherine RIOUFOL, PharmD

Conditions: Cancer, Oral chemotherapy, cancer outpatient, ONCORAL, medico-economic, Health related program, multidisciplinary, therapeutic education