A Phase 1/2 interventional study of HeartPhone app and Acetylcholine in Breast Cancer, Leukemia and Lymphoma, sponsored by Penn State University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Penn State University · Phase 1/2, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Main Study and Ancillary Study Exclusion Criteria:
Ancillary Study:
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
Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen)
Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter
Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor
This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine.
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)
Time frame: 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).
Time frame: 6 months
| Milestone | HeartPhone Intervention |
|---|---|
| Started | 2 |
| Completed | 0 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Change in the total physical activity volume from baseline to 3 months as measured by the Actigraph GT3XP-BTLE (total activity counts)
| Change in average daily activity counts | HeartPhone Intervention |
|---|---|
| Installation of the Heartphone Application. | 21155.05 |
Change in the total physical activity volume from baseline to 3 and 6 month as measured by the Actigraph GT3XP-BTLE (total activity counts).
| Participants | HeartPhone Intervention |
|---|---|
| Installation of the Heartphone Application. | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HeartPhone Intervention | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | HeartPhone Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | HeartPhone Intervention |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | HeartPhone Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Device-based physical activity volume(Total activity counts (vector magnitude)) | HeartPhone Intervention |
|---|---|
| Mean | 401977.9 ± 37898.2 |
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