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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Hematopoietic Cell Transplantation Recipient; Acute Leukemia in Remission
• Intervention / Treatment: Other: Questionnaire Administration; Device: Monitoring Device; Other: Informational Intervention; Other: Informational Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric Chow, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• Chow EJ, Doody DR, Di C, Armenian SH, Baker KS, Bricker JB, Gopal AK, Hagen AM, Ketterl TG, Lee SJ, Reding KW, Schenk JM, Syrjala KL, Taylor SA, Wang G, Neuhouser ML, Mendoza JA. Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2021 Aug;15(4):554-563. doi: 10.1007/s11764-020-00949-w. Epub 2020 Oct 10.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): June 16, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 10037 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2018-01168 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG1001769 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No