跳至主要内容
临床试验/NCT05501171
NCT05501171终止不适用

Randomized Controlled Trial of a Psychological Mobile Application (App) to Promote Coping for Patients With Acute Myeloid Leukemia (AML)

Massachusetts General Hospital6 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
6
主要终点
Anxiety Symptoms

研究概览

简要总结

This research study is evaluating whether a psychological mobile application (app), is efficacious in reducing anxiety and depression symptoms and improving quality of life for patients diagnosed with acute myeloid leukemia (AML) compared to a physical health promotion app.

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. 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.

From our prior studies, we learnt that the use of DREAMLAND, a psychological mobile app, was feasible to integrate in the care of patients with AML receiving intensive chemotherapy and has promising efficacy for improving patients' physical and psychological symptoms and their quality of life. In this project, the study doctors want to compare the effectiveness of DREAMLAND versus CERENA in improving the patient experience when diagnosed with AML. CERENA is a mobile app that provides medical information about how to best take care of one´s health. Using this research, the study doctors hope to find out the best way to help patients cope with the diagnosis and treatment for AML.

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. The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy.

Blue Note Therapeutics, Inc. is supporting this research study by providing funding. Blue Note Therapeutics is a digital health technology company that focuses on the health needs of patients with a cancer diagnosis.

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
Double (Care Provider, Investigator)

盲法说明

This is a double-blind multi-site randomized efficacy trial of two mobile apps: DreAMLand versus CERENA in 180 patients with AML. Patients will be recruited from 5 sites and randomized in 1:1 fashion, stratified by study site, to DreAMLand versus CERENA. The study investigators and clinicians caring for these patients will be blinded to the study group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients (aged 18 years or older) with a new diagnosis of AML
  • Receiving treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or b) a similar intensive regimen requiring prolonged 3-6-week hospitalization
  • Ability to comprehend and speak English as the mobile apps are only available in English

排除标准

  • Patients with a diagnosis of acute promyelocytic leukemia
  • Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

结局指标

主要结局

Anxiety Symptoms

时间窗: Day 20

Compare anxiety symptoms between participants receiving DREAMLAND versus CERENA as measured by the Hospital Anxiety and Depression Scale (HADS)-anxiety subscale over 20 days. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.

次要结局

  • Symptom Burden(Up to Day 90)
  • Anxiety Symptoms(Up to Day 90)
  • Quality of Life in Patients with Leukemia(Up to Day 90)
  • Depression Symptoms(Up to Day 90)
  • Post-Traumatic Stress Disorder (PTSD) Symptoms(Up to Day 90)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

El-Jawahri, Areej,M.D.

Principal Investigator

Massachusetts General Hospital

研究点 (6)

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