Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- The rate of prescriptions for chemotherapy in the outpatient clinic prepared at the latest the day before a session (except for predefined, limited stability products) and administered in full, per patient, during a follow-up period of 6 months
研究概览
简要总结
The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.
详细描述
Compare the two arms of the study in terms of:
A. each element contributing to the primary criterium;
B. the quality of chemotherapy related care;
C. logistics;
D. patient satisfaction with respect to support for chemotherapy care;
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
- •The patient was informed about the implementation of the study, its objectives, constraints and patient rights
- •The patient has given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 6 months of follow-up
- •The patient is treated via anti-cancer chemotherapy for colorectal cancer
- •The patient is starting a new adjuvant or metastatic chemotherapy protocol with a follow-up in a day-clinic setting
- •The patient has already used a smartphone, or desires to learn how, or is accompanied by a person who can help the patient use a smartphone
- •The anticipated chemotherapy treatment corresponds to one of the following protocols: cetuximab, FOLFIRI, FOLFIRI-aflibercept, FOLFIRI-bevacizumab, FOLFIRI-cetuximab, FOLFIRI-panitumumab, Folfirinox, Folfirinox-bevacizumab, Folfoxiri, Folfoxiri-bevacizumab, FOLFOX 4 simplified, FOLFOX 4 simplified - bevacizumab, FOLFOX 4 simplified - cetuximab, FOLFOX 4 simplified - panitumumab, Irinotecan-cetuximab, LV5FU2 simplified, panitumumab, XELOX.
排除标准
- •The patient is participating in another study, or has participated in another study within the past 3 months, that may influence the results or conclusions of the present trial
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, or is an adult under guardianship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The planned chemotherapy regimen includes weekly treatment cycles
- •Patient who is incapable of using a smartphone either by himself/herself or via another helping person
结局指标
主要结局
The rate of prescriptions for chemotherapy in the outpatient clinic prepared at the latest the day before a session (except for predefined, limited stability products) and administered in full, per patient, during a follow-up period of 6 months
时间窗: 6 months
This criterion is aggregated per patient but its components are collected for each prescription, according to the following coding: * Prescription prepared in advance and administered in full: 1 * Prescription prepared in advance but not administered in full: 0 * Prescription not prepared in advance : 0 For each patient, the sum of the results for each prescription will be the numerator. The denominator is the number of prescriptions during 6 months follow-up for each patient. The limited stability products that will necessarily be prepared at the last minute are: * Aflibercept * Panitumumab * Raltitrexed
次要结局
- The number of prescriptions prepared in advance and administered in full(6 months)
- The number of prescriptions prepared in advance and not administered in full(6 months)
- The number of prescriptions not prepared in advance(6 months)
- Dose-intensity per patient over 6 months of follow-up(6 months)
- The number of chemotherapy session postponements that were anticipated, and the patient was not required to come in to the clinic(6 months)
- The number of chemotherapy session postponements that were not anticipated, and the patient was required to come in to the clinic(6 months)
- The number of pharmaceutical interventions* accepted by the doctor / the number of prescriptions prepared for the totality of sessions(6 months)
- The number of chemotherapy sessions that really took place (c) during the 6 months of follow-up(6 months)
- The average number of days between chemotherapy sessions(6 months)
- The waiting time (on average) for the patient in the outpatient clinic before administration of the treatment(6 months)
- The number of pouches prepared, not administered and destroyed(6 months)
- The number of prescriptions that were prepared and administered(6 months)
- The number of pouches that were prepared, not-administered, but recycled(6 months)
- The average number of laboratory assessments required per chemotherapy session(6 months)
- Patient satisfaction vis-à-vis their chemotherapy care (Visual Analog Scale from 0.0 to 10.0)(6 months)
- Experimental arm per patient: The number Apicrypt transmissions / number of lab prescriptions(6 months)
- Experimental arm per patient: the number questionnaires filled out / the number of requested questionnaires(6 months)
- Experimental arm: Patient satisfaction vis-à-vis the ChimioPal tool (Visual Analog Scale from 0.0 to 10.0)(6 months)
- Overall costs(6 months)
- the total period of time spent by the patient in the outpatient clinic(6 months)