Clinical trial NCT03574012: SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
Official title: SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia in Remission
Hematopoietic Cell Transplantation Recipient
Lymphoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-06-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment rate among participants approached
timeFrame: Up to 1 year
measure: Retention rate among participants enrolled
timeFrame: Up to 1 year
measure: Participation in Facebook group
timeFrame: Up to 1 year
measure: Participation in Fitbit physical activity tracking
timeFrame: Up to 1 year
measure: Participation in Healthwatch diet tracking
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Eric Chow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.