Psychological Intervention Mobile App for Patients With AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Randomized Study of a Psychological Intervention Mobile Application (App) to Promote Coping in Patients With Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03372291
• Other study ID #: 17-542
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Usual Care
Usual leukemia care with all the supportive care measures instituted by the leukemia team
• Psychological intervention
Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility based on proportion of subjects enrolled and completing the app modules	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.	2 years
Secondary	Mood as measured by the Hospital Anxiety and Depression Scale (HADS)	Compare patient mood as measured by the Hospital Anxiety and Depression Scale (HADS) between the mobile app intervention and standard leukemia care. The HADS includes a depression and anxiety subscales (range 0 to 21) with higher scores indicating higher level of distress	up to day +40 after intensive chemotherapy
Secondary	Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9)	Compare patient depression symptoms as measured by the Patient Health Questionnaire (PHQ-9) between the mobile app intervention and standard leukemia care. The PHQ-9 has a score range of 0 to 27, with higher scores indicating worse depression symptoms.	up to day +40 after intensive chemotherapy
Secondary	Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk)	Compare patient QOL as measured by the Functional Assessment of Cancer Therapy (FACT-Leukemia) between the mobile app intervention and standard leukemia care. The FACT-Leukemia score ranges from 0 to 176 with higher scores indicating better quality of life.	up to day +40 after intensive chemotherapy
Secondary	Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS)	Compare patient symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS) between the mobile app intervention and standard leukemia care. ESAS scores range from 0 to 100 with higher scores indicating worse symptom burden.	up to day +40 after intensive chemotherapy
Secondary	Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)	Compare patient self-efficacy as measured by CASE between the mobile app intervention and standard leukemia care. The CASE has a score range of 0 to 170 with higher scores indicating a better sense of self-efficacy	up to day +40 after intensive chemotherapy