The Effect of a Mobile Application on Treatment Adherence and Symptom Management in Patients Using Oral Anticancer Agents: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change in Adherence to Oral Anticancer Agents
研究概览
简要总结
The use of oral anticancer agents (OAAs) in cancer treatment has increased especially in the last two decades. The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.The aim of this study is to explore how a Smartphone mobile application can help improve the cancer treatment process in people who are used oral anticancer agents. This study will be done a randomized-controlled trial to test the intervention.
详细描述
Background: The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.
Objective/Hipothesis: The purpose of this study is to explore the effectiveness of a mobile application on treatment adherence and symptom management in patients using OAA. The following hypotheses (H) will teste in this study:
H0a: A mobile application developed for patients using OAA has not increased treatment adherence.
H1a: A mobile application developed for patients using OAA has increased treatment adherence.
H0b: A mobile application developed for patients using OAA has not decreased the frequency and severity of symptoms.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Using OAAs for cancer treatment and taking at least one cure
- •Taking OAAs for at least six months
- •Knowing the diagnosis
- •Communicating verbally
- •Scoring less than three on the Eastern Cooperative Oncology Group (ECOG) scale
- •Having a smartphone with IOS or Android software
- •Actively using the smartphone
- •Consenting to download the mobile application on one's mobile phone
- •Volunteering to participate in the research.
排除标准
- •Participation in a similar study aimed at increasing treatment adherence
- •Having physical, cognitive, or memory-related problems that significantly impair one's daily activities
- •Having a smartphone with Windows or Blackberry software.
结局指标
主要结局
Change in Adherence to Oral Anticancer Agents
时间窗: baseline, 1 month, 3 months, 6 months
The patients' adherence levels will be assess using the Oral Chemotherapy Adherence Scale (OCAS). The OCAS was developed by Bagcivan and Akbayrak (2015), and its Cronbach α coefficient was found to be 0.738. The scale (19 items, 5-point Likert-type) is a valid and reliable scale for adult patients who use OAAs. A total score of 84 and above is interpreted as "good adherence;" a total score of 83 and below is interpreted as "poor adherence".
Change in Symptoms and Side Effects
时间窗: baseline, 1 month, 3 months, 6 months
The Memorial Symptom Assessment Scale (MSAS) is a multidimensional tool developed to evaluate the prevalence, characteristics, and distress levels of common cancer-related symptoms over seven days (Cronbach α=0.84). The MSAS is a reliable and valid instrument in the Turkish population. The scale has 32 items and three sub-dimensions: The Global Distress Index, The Physical Symptom Distress Scores, and The Psychologic Symptom Distress Scores. The total MSAS score is the average of the symptom scores of all 32 items. Twenty-four symptoms are evaluated in terms of severity, frequency and distress, and eight symptoms are evaluated in terms of severity and distress. If a symptom was experienced, the patient describes its severity on a 4-point categorical scale; its frequency, if appropriate, on a 4-point categorical scale; and its associated distress on a 5-point categorical scale. Each symptom score is the average of the dimensions (frequency, severity, distress dimensions).
次要结局
未报告次要终点
研究者
Akile Karaaslan Eşer
Assistant professor
Baskent University