SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
4 other identifiers
interventional
41
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedStudy Start
First participant enrolled
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2020
CompletedJanuary 23, 2024
September 1, 2020
1.4 years
June 19, 2018
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Control Group (general health information, fitness tracker)
ACTIVE COMPARATORParticipants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.
Intervention Group (individualized information, tracker)
EXPERIMENTALParticipants 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.
Interventions
Use Fitbit tracker
Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Related 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 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.
PMID: 33037989RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Chow
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2018
First Posted
June 29, 2018
Study Start
August 31, 2018
Primary Completion
January 22, 2020
Study Completion
June 16, 2020
Last Updated
January 23, 2024
Record last verified: 2020-09