Trial Outcomes & Findings for HeartPhone Cancer Survivors Trial 2019 (NCT NCT03953326)

Last Updated: 2026-02-27

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

3 months

Results posted on

2026-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	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. HeartPhone app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor 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.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. HeartPhone app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor 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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Study was terminated based on recruitment difficulties. The sample was too small to draw any meaningful inferences and was not analyzed further once futility was established. Specifically, we enrolled two participants who completed the baseline assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeartPhone Intervention n=2 Participants 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 app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor 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.
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants
Sex: Female, Male Female	2 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=24 Participants
Race (NIH/OMB) White	2 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants
Device-based physical activity volume	401977.9 Total activity counts (vector magnitude) STANDARD_DEVIATION 37898.2 • n=24 Participants • Study was terminated based on recruitment difficulties. The sample was too small to draw any meaningful inferences and was not analyzed further once futility was established. Specifically, we enrolled two participants who completed the baseline assessment.

PRIMARY outcome

Timeframe: 3 months

Population: Only one participant completed 3 month assessment and the study was terminated early due to futility in enrollment.

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

Outcome measures

Outcome measures
Measure	HeartPhone Intervention n=1 Participants 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 app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor 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.
Installation of the Heartphone Application.	21155.05 Change in average daily activity counts

PRIMARY outcome

Timeframe: 6 months

Population: Study was terminated prematurely due to futility in recruitment. No participants completed the 6 months assessment.

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

Outcome measures

Outcome measures
Measure	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. HeartPhone app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor 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.
Installation of the Heartphone Application.	0 Participants

Adverse Events

HeartPhone Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David E. Conroy

The Pennsylvania State University

Phone: 814-865-7935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place