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Behavioral Intervention

Digital App for Leukemia (NAVIGATE Trial)

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized patients (age > 18 years) with a diagnosis of AML

Ability to comprehend and speak English as the digital apps are only available in English

Must not have

Patients with a diagnosis of acute promyelocytic leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how a new self-administered digital app called DREAMLAND can help improve the quality of life and mental well-being of patients with acute myeloid leukemia who are undergoing

Who is the study for?

This trial is for hospitalized adults over 18 with acute myeloid leukemia (AML), starting intensive chemotherapy that requires a long hospital stay. Participants must understand and speak English as the digital apps are in English only. Those with acute promyelocytic leukemia or unstable psychiatric conditions can't join.

What is being tested?

The study tests a new self-administered digital app called DREAMLAND, aimed at improving life quality and mental health for AML patients during their intense chemotherapy treatment in the hospital.

What are the potential side effects?

Since this trial involves a digital application rather than medication, traditional side effects are not expected; however, users may experience discomfort or stress from using the technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and hospitalized with acute myeloid leukemia.

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I can understand and speak English.

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I am starting a strong chemotherapy that needs a long hospital stay.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale

Secondary study objectives

Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale

Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale

Participant depression symptoms as measured by the Hospital Anxiety Depression scale

+3 more

Other study objectives

Participant experience of application's usability as measured by the Systems Usability Scale

Participant perceived ability to used adaptive coping as measured by the Measure of Current Status Part A

Participant self-efficacy level as measured by the Cancer Self-Efficacy scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DREAMLANDExperimental Treatment1 Intervention

DREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy.

Group II: VITAL WELLNESSActive Control1 Intervention

VITAL WELLNESS is a self-administered, multicomponent mobile application containing information on a range of physical health topics that guide patients through education about general wellness, nutrition, exercise, and cancer prevention.

0 / 4Eligibility criteria met