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

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Acute Leukemia in Remission; Lymphoma; Hematopoietic Cell Transplantation Recipient

Treatments: Other: Informational Intervention; Other: Questionnaire Administration; Device: Monitoring Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03574012

NCI-2018-01168 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

10037 (Registry Identifier)

RG1001769 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Control Group (general health information, fitness tracker)

Active Comparator group

Description:

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

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Device: Monitoring Device

Intervention Group (individualized information, tracker)

Experimental group

Description:

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.

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Device: Monitoring Device