Psychological Intervention Mobile App for Patients With AML

NCT03372291 | Completed

• 1 other identifier: 17-542
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mood as measured by the Hospital Anxiety and Depression Scale (HADS)

  up to day +40 after intensive chemotherapy

• Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9)

  up to day +40 after intensive chemotherapy

• Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk)

  up to day +40 after intensive chemotherapy

• Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS)

  up to day +40 after intensive chemotherapy

• Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)

  up to day +40 after intensive chemotherapy

Study Arms (2)

Psychological app

EXPERIMENTAL

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

Other: Psychological intervention

Usual Care

ACTIVE COMPARATOR

* 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

Interventions

Usual Care OTHER

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

Usual Care

Psychological intervention OTHER

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

Psychological app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 38429079 DERIVED

• 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.

  PMID: 36655338 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: December 13, 2017
• Study Start: September 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)