NCT05501171

Brief Summary

This research study is evaluating whether a psychological mobile application (app), is efficacious in reducing anxiety and depression symptoms and improving quality of life for patients diagnosed with acute myeloid leukemia (AML) compared to a physical health promotion app.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

August 12, 2022

Last Update Submit

July 31, 2023

Conditions

AMLAcute Myeloid Leukemia

Keywords

AMLAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Anxiety Symptoms

    Compare anxiety symptoms between participants receiving DREAMLAND versus CERENA as measured by the Hospital Anxiety and Depression Scale (HADS)-anxiety subscale over 20 days. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.

    Day 20

Secondary Outcomes (5)

  • Anxiety Symptoms

    Up to Day 90

  • Depression Symptoms

    Up to Day 90

  • Quality of Life in Patients with Leukemia

    Up to Day 90

  • Symptom Burden

    Up to Day 90

  • Post-Traumatic Stress Disorder (PTSD) Symptoms

    Up to Day 90

Other Outcomes (3)

  • Coping

    Up to Day 90

  • Self-efficacy

    Up to Day 90

  • Health care utilization

    Up to 6 months

Study Arms (2)

DREAMLAND

EXPERIMENTAL

Participants will be recruited from 5 sites and randomized in 1:1 fashion, stratified by study site, to DREAMLAND versus CERENA. * Participants will use DREAMLAND and during hospitalization for treatment of AML to learn how to cope most effectively with the diagnosis of AML using an iPad provided by the study team or participant's own iPad. * Questionnaires (in-person, over the computer or telephone, or by mail) at predetermined days per protocol days.

Behavioral: DREAMLAND

CERENA

ACTIVE COMPARATOR

Participants will be recruited from 5 sites and randomized in 1:1 fashion, stratified by study site, to DREAMLAND versus CERENA. * Participants will use the mobile app CERENA during hospitalization for treatment of AML to learn how to best care for themselves using an iPad provided by the study team or participant's own iPad. * Questionnaires (in-person, over the computer or telephone, or by mail) at predetermined days per protocol days.

Behavioral: CERENA

Interventions

DREAMLANDBEHAVIORAL

DREAMLAND is self-administered psychological app for patients with AML that includes four modules, focused on: 1. Supportive psychotherapy strategies 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. 2. Psychoeducation to manage expectations and enhance preparedness for extended hospitalization and mobilize social support. 3. Psychosocial skill-building to promote effective coping strategies and facilitate acceptance while living with uncertainty. 4. Self-care to promote positive health behaviors and enhance patients´ sense of control especially as they transition from the hospital to outpatient care. Each module takes 20 minutes to complete. DREAMLAND also includes three optional models that also take 15 minutes to complete. Other names BNT200

DREAMLAND
CERENABEHAVIORAL

CERENA is a self-administered physical health app that includes 4 modules focused, focused on: 1. Education about general wellness. 2. Nutrition. 3. Exercise. 4. Cancer prevention. Each module takes 20 minutes to complete. CERENA also includes three optional modules that also take 15 minutes to complete.

CERENA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients (aged 18 years or older) with a new diagnosis of AML
  • Receiving treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or b) a similar intensive regimen requiring prolonged 3-6-week hospitalization
  • Ability to comprehend and speak English as the mobile apps are only available in English

You may not qualify if:

  • Patients with a diagnosis of acute promyelocytic leukemia
  • Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Areej El-Jawahri, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
This is a double-blind multi-site randomized efficacy trial of two mobile apps: DreAMLand versus CERENA in 180 patients with AML. Patients will be recruited from 5 sites and randomized in 1:1 fashion, stratified by study site, to DreAMLand versus CERENA. The study investigators and clinicians caring for these patients will be blinded to the study group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 15, 2022

Study Start

October 15, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(3)