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OpenTrials
Completed

NCT Number: NCT03574012

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monitoring Device

Device

Use Fitbit tracker

Informational intervention

Other

Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Enrollment rate among participants approached

    Time frame: Up to 1 year

  2. Retention rate among participants enrolled

    Time frame: Up to 1 year

    Retention is defined as completion of patient questionnaire and in-person assessment after 4-month intervention

  3. Participation in Facebook group

    Time frame: Up to 1 year

    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.)

  4. Participation in Fitbit physical activity tracking

    Time frame: Up to 1 year

    Number of participants who submit step count data on at least 50% of eligible days

  5. Participation in Healthwatch diet tracking

    Time frame: Up to 1 year

    Number of participants who provide dietary data on at least 75% of eligible days

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2018
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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