Psychological Intervention Mobile App for Patients With AML

NCT ID: NCT03372291

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2024-07-01

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

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 four sessions (20-25 minutes each) that patients will start during their first week of admission for intensive chemotherapy and continue weekly

Group Type: EXPERIMENTAL

Psychological intervention

Intervention Type: OTHER

Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual leukemia care with all the supportive care measures instituted by the leukemia team

Interventions

Usual Care

Usual leukemia care with all the supportive care measures instituted by the leukemia team

Intervention Type: OTHER

Psychological intervention

Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804.

Reference Type: DERIVED

PMID: 38429079 (View on PubMed)

El-Jawahri A, Luskin MR, Greer JA, Traeger L, Lavoie M, Vaughn DM, Andrews S, Yang D, Boateng KY, Newcomb RA, Ufere NN, Fathi AT, Hobbs G, Brunner A, Abel GA, Stone RM, DeAngelo DJ, Wadleigh M, Temel JS. Psychological mobile app for patients with acute myeloid leukemia: A pilot randomized clinical trial. Cancer. 2023 Apr 1;129(7):1075-1084. doi: 10.1002/cncr.34645. Epub 2023 Jan 18.

Reference Type: DERIVED

PMID: 36655338 (View on PubMed)

Other Identifiers

17-542

Identifier Type: -

Identifier Source: org_study_id