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

Study Overview
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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.

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.

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

Conditions
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Acute Leukemia in Remission, Hematopoietic Cell Transplantation Recipient, Lymphoma

Intervention / Treatment
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* Device: Monitoring Device
* Other: Informational Intervention
* Other: Informational Intervention
* Other: Questionnaire Administration


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (general health information, fitness tracker)<br>Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch. | Device: Monitoring Device<br>* Use Fitbit tracker<br>Other: Informational Intervention<br>* Receive general health and fitness information from clinician<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Intervention Group (individualized information, tracker)<br>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. | Device: Monitoring Device<br>* Use Fitbit tracker<br>Other: Informational Intervention<br>* Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate among participants approached |  | Up to 1 year | 
| Retention rate among participants enrolled | Retention is defined as completion of patient questionnaire and in-person assessment after 4-month intervention | Up to 1 year | 
| Participation in Facebook group | Number of participants who log onto the group page and participate at least one time (e.g., view a post, post something themselves, respond to a post [e.g., like a post], etc.) | Up to 1 year | 
| Participation in Fitbit physical activity tracking | Number of participants who submit step count data on at least 50% of eligible days | Up to 1 year | 
| Participation in Healthwatch diet tracking | Number of participants who provide dietary data on at least 75% of eligible days | Up to 1 year |