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Psychological Intervention Mobile App for Patients With AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372291
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Usual Care Other: Psychological intervention Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 five sessions (20-25 minutes each) that patients will start during their first week of admission for intensive chemotherapy and continue weekly for five weeks after diagnosis
 Other: Psychological intervention
Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment
Active Comparator: 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
 Other: Usual Care
Usual leukemia care with all the supportive care measures instituted by the leukemia team


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Emily Wright 617-643-9907 EMWRIGHT@mgh.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02114
Contact: Marlise Luskin, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emily Wright    617-643-9907    EMWRIGHT@mgh.harvard.edu   
Principal Investigator: Areej El-Jawahri, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital
More Information
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Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03372291    
Other Study ID Numbers: 17-542
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Acute Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms