Clinical trial NCT03372291: Psychological Intervention Mobile App for Patients With AML
Official title: Randomized Study of a Psychological Intervention Mobile Application (App) to Promote Coping in Patients With Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility based on proportion of subjects enrolled and completing the app modules
timeFrame: 2 years
Secondary outcomes:
measure: Mood as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to day +40 after intensive chemotherapy
measure: Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9)
timeFrame: up to day +40 after intensive chemotherapy
measure: Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk)
timeFrame: up to day +40 after intensive chemotherapy
measure: Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS)
timeFrame: up to day +40 after intensive chemotherapy
measure: Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)
timeFrame: up to day +40 after intensive chemotherapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: