ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 18
- 主要终点
- Adherence evaluated by MicroElectronic Monitoring System
研究概览
简要总结
As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized.
PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being.
ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 70 years,
- •For which oral anticancer therapy has been initiated within the previous 45 days or will be started within 45 days
- •For any type of cancer, solid or hematologic, any stage
- •Estimated life expectancy> 6 months
- •Affiliation to social security or equivalent
- •Patients who can answer questionnaires and protocol evaluations
- •Informed consent signed by patients
- •Domiciled within 50 km around the investigating center
排除标准
- •For patients with breast cancer, exclusive treatment with hormone therapy
- •First-generation Hormone Therapy in Prostate Cancer
- •Patient not available for regular follow-up whatever the cause (geographic, family, social, psychological)
- •Any serious condition, ie serious physical or mental, leading to a disability permanent and likely to prevent the proper course of treatment
- •Patient deprived of liberty or under guardianship
结局指标
主要结局
Adherence evaluated by MicroElectronic Monitoring System
时间窗: at 4 months (after intervention or information)
Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.
次要结局
- Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire(4 months to 12 months)
- Adherence evaluated by Morisky questionnaires(4 months to 12 months)
- Adherence evaluated by pharmacy medication refill -based adherence(4 months to 12 months)
- Health-related quality of life evaluated by the EORTC quality of life questionnaire(4 months to 12 months)
- Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire(4 months to 12 months)
- Changes in patients' behaviors evaluated by questionnaires(4 months to 12 months)