SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-06-16

Brief Summary

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This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (HCT) survivors in a randomized cardiovascular (CV) risk reduction mobile health (mHealth) counseling intervention.

II. Develop and refine a protocol to engage participants using an existing social medial platform and commercially available mHealth tools to reinforce lifestyle goals.

OUTLINE: Participants are randomized to 1 of 2 groups.

INTERVENTION GROUP: Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.

CONTROL GROUP: Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.

After completion of study treatment, participants are followed up at 2 months and at 1 year.

Conditions

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Acute Leukemia in Remission Hematopoietic Cell Transplantation Recipient Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control Group (general health information, fitness tracker)

Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.

Group Type ACTIVE_COMPARATOR

Monitoring Device

Intervention Type DEVICE

Use Fitbit tracker

Informational Intervention

Intervention Type OTHER

Receive general health and fitness information from clinician

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Intervention Group (individualized information, tracker)

Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.

Group Type EXPERIMENTAL

Monitoring Device

Intervention Type DEVICE

Use Fitbit tracker

Informational Intervention

Intervention Type OTHER

Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Monitoring Device

Use Fitbit tracker

Intervention Type DEVICE

Informational Intervention

Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform

Intervention Type OTHER

Informational Intervention

Receive general health and fitness information from clinician

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.
* At time of approach, \>= 5 years from initial cancer diagnosis or \>= 5 years from first HCT, whichever is later.
* Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).
* Able to read, write, and speak English.
* Access to smart phone or computer with internet access.
* Presence of at least 1 CV risk factor:

* Currently on medication for hypertension, or
* Currently on medication for cholesterol or triglyceride, or
* Currently on medication for diabetes, or
* Currently not physically active (self-reported average \< 30 minutes/day), or
* Currently smoking.
* Ability to understand and the willingness to provide informed consent.

Exclusion Criteria

* Pre-existing ischemic heart disease (includes angina if documented in electronic medical record \[EMR\]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing).
* Active systemic treatment for graft versus host disease.
* Currently pregnant. However, participants enrolled who become pregnant after randomization can remain on the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No