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



Status:Recruiting
Conditions:Other Indications, Blood Cancer, Lymphoma
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - 55
Updated:1/25/2019
Start Date:August 31, 2018
End Date:August 15, 2020

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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.

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.

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.
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Eric J. Chow
Phone: 206-667-4630
?
mi
from
Seattle, WA
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