The Effect of Mobile Application-Based Education Developed According to Orem's Self-Care Model on Enhancing Self-Care Agency in Patients With Multiple Myeloma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Self-Care Agency Score
研究概览
简要总结
This randomized controlled trial aims to assess the effectiveness of a mobile application-based education program, developed according to Orem's Self-Care Model, in improving self-care agency and quality of life among patients with multiple myeloma in Turkey. Participants are recruited from the outpatient clinic of a hospital and randomly assigned to either the intervention or control group. The intervention group uses the mobile application for 24 weeks, while the control group continues with routine care and receives a standard one-page brochure commonly distributed to cancer patients. All participants complete a demographic form, the EORTC QLQ-C30, QLQ-MY20, and the Self-Care Agency Scale at baseline, week 12, and week 24. The collected data will be used to compare changes in self-care agency and quality of life between the two groups over time.
详细描述
This study was conducted to address the self-care needs of patients diagnosed with multiple myeloma, a chronic and complex hematologic cancer. Based on Orem's Self-Care Deficit Nursing Theory, a mobile application was developed to improve patients' self-care agency and quality of life. The intervention group uses the mobile application for 24 weeks, which includes educational content, self-monitoring features, and motivational messages. The control group receives routine care, which includes standard medical follow-up and a one-page general information brochure commonly provided to cancer patients at the hospital. Self-care agency and quality of life are assessed using the Self-Care Agency Scale, EORTC QLQ-C30, and EORTC QLQ-MY20 at three time points: baseline, week 12, and week 24. The results are expected to contribute to evidence-based self-care interventions for patients with hematologic malignancies.
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 (Participant)
盲法说明
Participants were blinded to their group assignment. The investigator was aware of group allocation, as the study is a doctoral thesis project.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with multiple myeloma and received at least one course of treatment
- •Age 18 or older
- •Able to speak and read Turkish
- •ECOG performance status of I, II, or III
- •Has used at least one Android-based digital tool (e.g., sending text messages, email, using mobile apps)
- •Literate (able to read and write)
- •Willing to participate and able to provide written informed consent
排除标准
- •Not currently diagnosed with multiple myeloma
- •Has cognitive or psychological disorders that prevent completing questionnaires or using the mobile application
- •Unable to speak or understand Turkish
- •Unwilling or unable to provide written informed consent
研究组 & 干预措施
Control Group
Participants received routine care and a one-page standard information brochure for cancer patients.
Intervention Group
A mobile application was provided to support self-care and quality of life, based on Orem's Self-Care Deficit Model. Patients were asked to use it regularly for 24 weeks.
干预措施: Mobile App Education (Behavioral)
结局指标
主要结局
Change in Self-Care Agency Score
时间窗: Baseline, 12th week, and 24th week
Self-care agency was assessed using the Self-Care Agency Scale.
次要结局
未报告次要终点
研究者
Ozlem
Professor, Faculty of Nursing, Dokuz Eylul University
Dokuz Eylul University