Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Adherence: drug accountability
研究概览
简要总结
This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.
A total of 124 patients will be considered.
Patients will be randomized 1:1 to one of the following interventions:
A. electronic diary B. paper diary The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.
详细描述
This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.
The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.
The secondary objectives of the study are:
- describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription),
- describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire
- description of the costs related to therapeutic non-adherence. A total of 124 patients will be considered: enrollment will take place consecutively until the predetermined number is reached.
Eligible patients will be randomized in a 1:1 ratio using a balanced procedure a blocks exchanged to one of the following interventions, stratified by type of therapy (chemotherapy vs. biological therapy): A. electronic diary B. paper diary The electronic diary consist of an Android app (for Android version 2.2 and later) for mobile devices, which acts as a diary for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •≥ 18 years old (both genders)
- •Eastern Cooperative Oncology Group (ECOG) ≤2
- •Patients with solid and haematological neoplasia (adjuvant or advanced setting) candidates to treatment with oral therapy.
排除标准
- •Patients who also receive anticancer treatment intravenously, as such patients access the hospital regularly and are in closer contact with healthcare personnel.
- •Patients receiving experimental cancer treatment
- •Patients who are unable to cooperate with study procedures (in the researcher's opinion)
- •Patients who are candidates for oral drug treatment lasting less than 3 months.
- •Patients with a life expectancy <12 weeks.
- •All patients being treated with drugs not listed in the Protocol Appendix C.
研究组 & 干预措施
A. electronic diary (TreC-Onco)
At the baseline visit, each patient assigned to arm A will be provided with the electronic diary (installed on a smart phone or tablet), the oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the electronic diary, and the user manual will also be given. This app allows patients to record parameters related to their health state (e.g. medications, blood pressure, weight, fever, side effects or other symptoms) and through the "alarm" function, it reminds the patient to take the tablets, indicating the exact dosage. In addition, the patient can also indicate the dose reduction or the omission.
干预措施: TreC-Onco (Device)
B. paper diary
Patients assigned to arm B will be provided with a paper diary, oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the paper diary.
干预措施: Paper diary (Other)
结局指标
主要结局
Adherence: drug accountability
时间窗: 36 months
To assess the effectiveness of the electronic diary in improving adherence to oral therapy. Adherence will be assessed at each treatment cycle by counting the remaining tablets, and tested using Fisher's exact test. The number of pills counted by the system will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit.
次要结局
- non-adherence reasons(36 months)
- Patient compliance(36 months)
- cost analysis(36 months)