Clinical trial NCT03660670: Medico-economic Evaluation of the ONCORAL Program for Ambulatory Patients Under Oral Anticancer Drugs Versus Usual Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Oral chemotherapy
cancer outpatient
ONCORAL
medico-economic
Health related program
multidisciplinary
therapeutic education
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Evaluate efficiency of ONCORAL program for ambulatory patients under oral anticancer drugs versus usual care
timeFrame: Month 12
Secondary outcomes:
measure: Evaluate the cost price in charge for the two strategies
timeFrame: Month 12
measure: Patient's quality of life, measured with the EQ-5D-3L (EuroQol Group-5 dimensions-3 levels) questionnaire
timeFrame: at inclusion, 3 months, 6 months and 12 months post inclusion
measure: Budget impact analysis of 12-months of ONCORAL care.
timeFrame: 12 months
measure: Oral anti-cancer dose taken relative to the dose of the marketing authorization
timeFrame: 3, 6 and 12 months post-inclusion
measure: Reasons for modifications of relative dose-intensity
timeFrame: 3, 6 and 12 months post-inclusion
measure: Observance of oral anti-cancer drugs
timeFrame: 3, 6 and 12 months post-inclusion
measure: Adverse events related to oral anti-cancer drug
timeFrame: From baseline to 12 months
measure: Drug interactions
timeFrame: From baseline to 12 months
measure: Medication errors
timeFrame: From baseline to 12 months
measure: Overal survival evaluation
timeFrame: 12 months
measure: Progression free survival evaluation
timeFrame: 12 months
measure: Patient Satisfaction Score for Therapeutic care
timeFrame: 3, 6, 9 and 12 months
measure: Disease representation from patient
timeFrame: baseline, 6 months and 12 months
measure: Treatment representation from patient's point of view
timeFrame: baseline, 6 months and 12 months
measure: Perceived social support
timeFrame: 6 and 12 months
measure: Health locus of control of the patient
timeFrame: baseline, 6 months and 12 months post-inclusion
measure: Quality of life of patients
timeFrame: baseline, 3 months, 6 months, and 12 months post-inclusion
measure: For investigational arm : patient's reported adverse events
timeFrame: From baseline to 12 months
measure: Satisfaction of first resort (doctor, pharmacist and liberal nurse)
timeFrame: 12 months
measure: Satisfaction of patient
timeFrame: 12 months
measure: Types of pharmaceutical interventions
timeFrame: 12 months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Catherine RIOUFOL, PharmD
role: PRINCIPAL_INVESTIGATOR
References: