Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.
研究概览
简要总结
Multiple Myeloma is an incurable cancer. Therapies for it include oral chemotherapy pills. It is unknown whether patients regularly and correctly take these anti-myeloma pills. This study wants to measure the rate of adults with MM taking anti-myeloma pills correctly. The investigators also want to use a teaching tool to see if it will help patients feel more satisfied and more confident in taking their anti-myeloma pills correctly. The investigators hope to use this data from this small study to eventually do a larger study in this area.
详细描述
The prevalence of patients with myeloma utilizing orally-administered myeloma therapy (OMT) is expected to continuously rise within Canada. The MASCC Oral agent Teaching Tool (MOATT) interventional tool relies on the concept of improved patient education in turn leading to improved adherence. Although the MOATT intervention is currently endorsed by Cancer Care Ontario, there is no data using the MOATT intervention in patients with myeloma or within Canada. Prior to embarking on a larger, multi-center study, a pilot study is necessary to 1) understand the feasibility, acceptability of the MOATT intervention and its preliminary efficacy 2) to determine the rates of adherence to OMT and explore factors associated with non-adherence and 3) to determine the feasibility of a larger multi-centre trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Will include adults (age>18) with multiple myeloma who will be initiating OMT (lenalidomide or pomalidomide in the next 6 months) for either newly diagnosed, maintenance-phase or relapsed myeloma at the JCC
排除标准
- •Patients who reside in a facility in which their medications are administered to them (such as a nursing home)
结局指标
主要结局
Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.
时间窗: 18 months from study recruitment date.
Patient's preference and acceptability of using the MOATT intervention will be assessed using a 5 point Likert Scale after the intervention is completed. A higher score means a higher level of personal satisfaction and acceptance of the MOATT intervention.
次要结局
- Objective adherence rate of medication assessed by number of cap openings.(18 months from study recruitment date.)
- Self Reported Adherence Rate assessed by Brief Adherence Rating Scale (BARS).(18 months from study recruitment date.)
- Toxicities of Oral Myeloma Treatment assessed by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE tool).(18 months from study recruitment date.)
研究者
Hira Mian
Hematologist, Juravinski Cancer Center Assistant Professor, Department of Oncology, McMaster University
Hamilton Health Sciences Corporation