Trial of a Smartphone Application to Improve Medication Adherence Among Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of subjects enrolled that complete the 12-week intervention and assessments
研究概览
简要总结
For this current proposal, the investigator will conduct a single-center prospective non-randomized pilot interventional study in patients with any stage and type of cancer who are either taking at least one OACD or are taking at least one oral medication for chronic condition management in conjunction with any cancer treatment.
Primary Objective: To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients either receiving oral anticancer agents (OACDs) or receiving oral medications for chronic disease management (non-OACDs) in conjunction with non-oral cancer treatment.
Secondary Objectives: To compare and characterize medication adherence before and after the 12-week intervention using the Voils Extent of Adherence Scale and the Medisafe App. Also to determine the acceptability, utility and patient engagement with the App, to evaluate changes in healthcare related quality of life before and after the intervention, and to explore behaviors, knowledge, attitudes and beliefs related to medication adherence using a semi-structured interview delivered over the telephone.
详细描述
Many patients with cancer experience frustration with the large number and complex scheduling of their medications. This study will help find out how much "pill burden" exists in patients with cancer, and how a smartphone app can help patients take medications as providers prescribe. Results of this study may help figure out the best way to help patients manage medications in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Any type/stage cancer
- •Patients must be taking either:
- •at least one oral anti-cancer drug (OACD) or
- •at least one oral medication (non-OACD) for management of a chronic condition in addition to receiving non-oral cancer treatment
- •Patients must have access to a mobile phone or tablet that can download the Medisafe App. (ie apple/android)
- •Subjects must be able to complete self-administered questionnaires in English or Spanish.
- •Co-enrollment in trials involving pharmacologic therapy is allowed.
排除标准
- •Inability to provide informed consent
研究组 & 干预措施
Smartphone App Intervention
Cancer patients taking at least one oral anti-cancer drug or oral medication to manage a chronic condition in conjunction with any cancer treatment will receive messages through the Medisafe App.
干预措施: Smartphone App (Other)
结局指标
主要结局
Proportion of subjects enrolled that complete the 12-week intervention and assessments
时间窗: 12 weeks
To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients. Feasibility defined as completing the 12-week intervention and the endpoint assessments. Patients will be tallied.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Score before and after the intervention(Baseline and 12 weeks)
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Score before and after the intervention(Baseline and 12 weeks)
- Change in mean score on the Voils Extent of Adherence Scale for oral caner therapy use between baseline and 12 weeks(Baseline and 12 weeks)
- Change in mean score on the Voils Extent of Adherence Scale for global medication use between baseline and 12 weeks(Baseline and 12 weeks)
- Mean Score to Medication Self-Efficacy Scale (MASES) to assess a patient's confidence in their ability to take their medications in a variety of situations(12 weeks)
- Mean Score on the User Version of the Mobile Application Rating Scale(12 weeks)
研究者
Melissa K Accordino
Assistant Professor of Medicine, Division of Hematology/Oncology
Columbia University