Medico-economic Evaluation of the ONCORAL Program for Ambulatory Patients Under Oral Anticancer Drugs Versus Usual Care (ONCORAL-PRME)
Status
Conditions
Treatments
Details and patient eligibility
About
Economic impact of cancer treatments is increasing for years: increase of number of patients (385 000 new occurrences in 2015), increase of life expectancies, chronicization of diseases and increase of therapeutic innovation costs.
Oral anticancer drugs allow the ambulatory turn in oncologic treatments, avoid hospitalizations dues to injectable chemotherapies and improve patient autonomy. In real life situation, these drugs still remain linked to significant drug iatrogenic effects: prevalent adverse events and potentially serious ones, drugs interactions for one other patient, considered as major in 15-20% cases, and non-observance for 30-50% patients.
The resultant care overconsumption and the high cost of new oral targeted therapies appear as a substantial financial charge to the Health related program. Securing oral chemotherapy and their good practice therefore represent a real economic challenge and lead health care professionals to develop town-hospital programs of ambulatory patient's follow-up under oral anticancer drug in response of third Cancer Plan.
Benefice of such interventions are proved on observance, management of adverse events and drug interactions.
However, the effectiveness of these programs has not been evaluated and no studies have been conducted in France.
The Investigators propose here to carry out a medico-economic study of high level of proof of the ONCORAL program. This study will be the first evaluation of the effectiveness of a program for monitoring outpatient oral cancer patients versus usual care.
The results of this study will contribute to the national reflection on the path of care of patients treated by oral chemotherapy, on the assessment of needs and the evolution of the supply of care and its financing.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
215 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Magali MAIRE; Catherine RIOUFOL, PharmD
Data sourced from clinicaltrials.gov
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