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Medico-economic Evaluation of the ONCORAL Program for Ambulatory Patients Under Oral Anticancer Drugs Versus Usual Care

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03660670
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hospices Civils de Lyon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Catherine RIOUFOL, PharmD
Principal Investigator Affiliation Hospices Civils de Lyon
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer
Arms & Interventions

Arms

Experimental: Interventional Arm

Application of the ONCORAL program of multidisciplinary ONCOlogic interventions between town and hospital (doctor-pharmacist-nurse) for ambulatory patients under oRAL anticancer drugs

Sham Comparator: Standard of care

Patients in the control group will receive regular follow-up from their oncologist, but no more that the standard care.

Interventions

Behavioral: - ONCORAL therapeutic education

Multidisciplinary program that includes informative cessions with a hospital pharmacist about the anticancer drug: information is given to the patients on adverse events and their managements, optimizing drug dosage plans. Moreover, information is shared with town partners: doctor, pharmacists, and nurses.

Behavioral: - Standard of care

In the group of standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessments.

Contact a Trial Team

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International Sites

Centre Hospitalier Lyon Sud, Pierre-Bénite, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud

Pierre-Bénite, ,

Site Contact

Catherine RIOUFOL, PharmD

[email protected]

04 78 86 43 70 #+33

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