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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Evaluate efficiency of ONCORAL program for ambulatory patients under oral anticancer drugs versus usual care
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate efficiency of ONCORAL program for ambulatory patients under oral anticancer drugs versus usual care
时间窗: Month 12
Efficiency is calculated on the double dimension cost and year of life corrected by quality of life (QALY).
次要结局
- Oral anti-cancer dose taken relative to the dose of the marketing authorization(3, 6 and 12 months post-inclusion)
- Reasons for modifications of relative dose-intensity(3, 6 and 12 months post-inclusion)
- Evaluate the cost price in charge for the two strategies(Month 12)
- Drug interactions(From baseline to 12 months)
- Patient's quality of life, measured with the EQ-5D-3L (EuroQol Group-5 dimensions-3 levels) questionnaire(at inclusion, 3 months, 6 months and 12 months post inclusion)
- Adverse events related to oral anti-cancer drug(From baseline to 12 months)
- Budget impact analysis of 12-months of ONCORAL care.(12 months)
- Medication errors(From baseline to 12 months)
- Patient Satisfaction Score for Therapeutic care(3, 6, 9 and 12 months)
- Health locus of control of the patient(baseline, 6 months and 12 months post-inclusion)
- Types of pharmaceutical interventions(12 months)
- Observance of oral anti-cancer drugs(3, 6 and 12 months post-inclusion)
- Progression free survival evaluation(12 months)
- Treatment representation from patient's point of view(baseline, 6 months and 12 months)
- Quality of life of patients(baseline, 3 months, 6 months, and 12 months post-inclusion)
- For investigational arm : patient's reported adverse events(From baseline to 12 months)
- Satisfaction of patient(12 months)
- Perceived social support(6 and 12 months)
- Overal survival evaluation(12 months)
- Satisfaction of first resort (doctor, pharmacist and liberal nurse)(12 months)
- Disease representation from patient(baseline, 6 months and 12 months)