Randomized Study of a Psychological Intervention Mobile Application (App) to Promote Coping in Patients With Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility based on proportion of subjects enrolled and completing the app modules
研究概览
简要总结
This research study is evaluating the impact of a psychological intervention mobile application (app) on the quality of life, mood, and symptoms of patients with acute myeloid leukemia (AML).
详细描述
Patients with a new diagnosis of AML often confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6 week hospitalization to initiate intensive chemotherapy. During this hospitalization, they endure substantial physical symptoms due to the side-effects of intensive chemotherapy, which negatively impacts their quality of life (QOL). Patients with AML also experience significant psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during their hospitalization, and complete loss of independence. The study doctors want to know if the use of a mobile application (app) focused on helping patients cope with the diagnosis and treatment can reduce the distressing symptoms and improve the their quality of life and care.
The main purpose of this research study is see if a mobile app is feasible to use for patients with new diagnosis of AML and is acceptable to them. The study will also compare two types of care - standard leukemia care and standard leukemia care with the mobile app to see which is better for improving the experience of patients newly diagnosed with AML undergoing treatment.
The purpose of this research study is to find out whether using the mobile app that is focused on educating patients about leukemia and how to cope with its treatment can improve the physical and psychological symptoms that patients experience during hospitalization for their leukemia care. Using this research, the study doctors hope to find out the best way to help patients cope with their diagnosis and treatment for acute myeloid leukemia.
The study will use questionnaires to measure patient's quality of life, physical symptoms, mood, and the participant sense of control over their situation. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed. The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years).
- •New diagnosis of acute myeloid leukemia.
- •Admitted to Massachusetts General Hospital for intensive induction chemotherapy requiring 4-6-week hospitalization.
- •The ability to provide informed consent.
- •Ability to comprehend and speak English.
排除标准
- •Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder,
- •Major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
研究组 & 干预措施
Psychological app
Psychological intervention consist of four components
- Supportive psychotherapy interventions to help patients deal with the initial shock of diagnosis, cope with the loss of independence and abrupt life disruptions, and provide validation and reassurance;
- Psychoeducation to manage expectations and enhance preparedness for extended hospitalization and mobilize social supports;
- Psychosocial skill-building to promote effective coping strategies and facilitate acceptance while living with uncertainty;
- Self-care to promote positive health behaviors and enhance patients' sense of control especially as they transition from the hospital to outpatient care.
- The psychological intervention will consist of four sessions (20-25 minutes each) that patients will start during their first week of admission for intensive chemotherapy and continue weekly
干预措施: Psychological intervention (Other)
Usual Care
- Participants receiving usual care will not have access to the psychological intervention app. -They will receive usual leukemia care with all the supportive care measures instituted by the leukemia team.
- Patients in usual care will also meet with the leukemia social worker based on their request or at the discretion of the treating leukemia team
干预措施: Usual Care (Other)
结局指标
主要结局
Feasibility based on proportion of subjects enrolled and completing the app modules
时间窗: 2 years
The intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study and for those enrolled, they must complete at least 60% of the intervention modules.
次要结局
- Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk)(up to day +40 after intensive chemotherapy)
- Mood as measured by the Hospital Anxiety and Depression Scale (HADS)(up to day +40 after intensive chemotherapy)
- Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9)(up to day +40 after intensive chemotherapy)
- Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)(up to day +40 after intensive chemotherapy)
- Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS)(up to day +40 after intensive chemotherapy)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital