HeartPhone Cancer Survivors Trial 2019

Phase 1

Terminated

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

• Registration Number: NCT03953326
• Lead Sponsor: Penn State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HeartPhone Intervention	HeartPhone app	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.
HeartPhone Intervention	Acetylcholine	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.
HeartPhone Intervention	L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester	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.
HeartPhone Intervention	Sodium Nitroprusside	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.

Primary Outcome Measures

Name	Time	Method
Physical activity volume	3 month	Daily step counts over 1-week from Fitbit device

Secondary Outcome Measures

Name	Time	Method
Microvessel function	3 month	Skin blood flow during perfusion of endothelium-dependent and independent agonists

Trial Locations

Locations (1)

The Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States