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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574012
• Other study ID #: 10037
• Secondary ID: NCI-2018-0116810
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: June 16, 2020

Study information

• Verified date: September 2020
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 16, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Leukemia in Remission
• Hematopoietic Cell Transplantation Recipient
• Lymphoma

Intervention

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
• Informational Intervention
Receive general health and fitness information from clinician
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate among participants approached		Up to 1 year
Primary	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
Primary	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
Primary	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
Primary	Participation in Healthwatch diet tracking	Number of participants who provide dietary data on at least 75% of eligible days	Up to 1 year