HeartPhone Cancer Survivors Trial 2019

NCT03953326 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 00011271
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Installation of the Heartphone Application.

  Change in the total physical activity volume from baseline to 3 months as measured by the Actigraph GT3XP-BTLE (total activity counts)

  3 months

• Installation of the Heartphone Application.

  Change in the total physical activity volume from baseline to 3 and 6 month as measured by the Actigraph GT3XP-BTLE (total activity counts).

  6 months

Study Arms (1)

HeartPhone Intervention

EXPERIMENTAL

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; Drug: Acetylcholine; Drug: Sodium Nitroprusside; Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester

Interventions

HeartPhone app BEHAVIORAL

Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen)

HeartPhone Intervention

Acetylcholine DRUG

Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter

HeartPhone Intervention

Sodium Nitroprusside DRUG

Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor

HeartPhone Intervention

L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester DRUG

This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine.

HeartPhone Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently receiving curative treatment for cancer
• + 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)

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Leukemia; Lymphoma

Interventions

Acetylcholine; Nitroprusside; Tosylarginine Methyl Ester

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Amines; Amines; Organic Chemicals; Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds; Toluene; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Tosyl Compounds; Sulfones; Sulfur Compounds; Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Results Point of Contact

• Title: Dr. David E. Conroy
• Organization: The Pennsylvania State University

dec9@psu.edu

814-865-7935

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-group pre-post change

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: April 23, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)