Psychological Intervention Mobile App for Patients With AML
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|ClinicalTrials.gov Identifier: NCT03372291|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2017
Last Update Posted : April 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Other: Usual Care Other: Psychological intervention||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Study of a Psychological Intervention Mobile Application (App) to Promote Coping in Patients With Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||September 1, 2018|
|Actual Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Psychological app
Psychological intervention consist of four components
Other: Psychological intervention
Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment
Active Comparator: Usual Care
Other: Usual Care
Usual leukemia care with all the supportive care measures instituted by the leukemia team
- Feasibility based on proportion of subjects enrolled and completing the app modules [ Time Frame: 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.
- Mood as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: up to day +40 after intensive chemotherapy ]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
- Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9) [ Time Frame: up to day +40 after intensive chemotherapy ]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.
- Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk) [ Time Frame: up to day +40 after intensive chemotherapy ]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.
- Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: up to day +40 after intensive chemotherapy ]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.
- Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE) [ Time Frame: up to day +40 after intensive chemotherapy ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372291
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02114|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Areej El-Jawahri, MD||Massachusetts General Hospital|