HeartPhone Cancer Survivors Trial 2019

Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors

This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.

Study Overview

• Status: Terminated
• Conditions: Lymphoma; Leukemia; Breast Cancer
• Intervention / Treatment: Behavioral: HeartPhone app; Drug: Acetylcholine; Drug: Sodium Nitroprusside; Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-65 years
• Diagnosis of breast cancer, leukemia, or lymphoma <15 yrs
• Completed chemotherapy with cardiotoxic anthracycline-based agents 1+ year ago
• English-proficiency
• Own & use smartphone with Android operating system

Main Study and Ancillary Study Exclusion Criteria:

• Currently receiving curative treatment for cancer
• 90+ min/week moderate (or greater) intensity PA
• Any medical contraindications on the Physical Activity Readiness Questionnaire
• Require an assistive device for mobility or has any other condition that may limit or prevent participation in moderate-intensity physical activity
• Current smoker
• Pregnant or planning to become pregnant in the next 6 mos/breastfeeding
• Allergy to test substances
• Allergy to latex

Ancillary Study:

• Taking metformin
• Current medications that could conceivably alter the cardiovascular or thermoregulatory control or responses (e.g. beta blockers, calcium channel blockers, angiotensin receptor blockers)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HeartPhone Intervention; Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity.

Behavioral: HeartPhone app; Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen); Drug: Acetylcholine; Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter; Drug: Sodium Nitroprusside; Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor; Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester; This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity volume	Daily step counts over 1-week from Fitbit device	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvessel function	Skin blood flow during perfusion of endothelium-dependent and independent agonists	3 month

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Cholinergic Agents; Cholinergic Agonists; Nitric Oxide Donors; Nitroprusside; Acetylcholine
• Other Study ID Numbers: 00011271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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