Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 10
- 主要终点
- Time until decrease in quality of life by 5-points between groups
研究概览
简要总结
Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.
Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.
Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.
Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
- •Patient able to use a connected electronic object
- •Patient with a smartphone/tablet or computer with internet access and an email address.
- •Patient with WHO status ≤2
- •Patients receiving other cancer therapy concurrently with oral therapy may be included
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient pregnant, parturient or breast feeding
- •Illiterate patient
- •Patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
- •Patient receiving hormone therapy alone for breast or prostate cancer
结局指标
主要结局
Time until decrease in quality of life by 5-points between groups
时间窗: End of follow-up maximum 18 months
Quality of life calculated every 3 months using EORTC QLQ-C30 for which a decrease of 5-points is considered to be the minimal clinically important difference
次要结局
- Medication observance(18 months)
- Time until progression of cancer between groups(End of follow-up maximum 18 months)
- Quality of life adjusted years between groups(18 months)
- Cost of care between groups(End of study (18 months))
- Budget Impact Analysis(After 2 years)
- Toxicity experienced during treatment between groups(18 months)
- Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes(Month 18)
- Patient satisfaction with their treatment between groups(18 months)
- Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).(18 months)
- Relative Dose Intensity between groups(18 months)