Breast CancerPhase 1/2NCT03953326
HeartPhone Cancer Survivors Trial 2019
A Phase 1/2 study testing HeartPhone app, Acetylcholine and Sodium Nitroprusside in people with Breast Cancer and Leukemia, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Leukemia, Lymphoma
- What is being tested?
- HeartPhone app, Acetylcholine and Sodium Nitroprusside
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 31 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: 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.
- Conditions
- Breast Cancer, Leukemia, Lymphoma
- Being tested
- HeartPhone app, Acetylcholine, Sodium Nitroprusside, L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester
- Medical subject headings
- Breast Neoplasms, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartPhone appBehavioural
Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen)
AcetylcholineDrug
Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter
Sodium NitroprussideDrug
Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor
L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl EsterDrug
This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HeartPhone app; Drug: Acetylcholine; Drug: Sodium Nitroprusside; Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start23 Apr 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Futility in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pre-post change
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E Conroy, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953326
- Sponsor's protocol ID
- 00011271
- Status last verified
- Feb 2026
- First submitted
- 13 May 2019
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT03953326
- Acronym / sponsor ID
- 00011271
- Conditions
- Breast Cancer, Leukemia, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility in recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pre-post change
| Arm | Type | Receives |
|---|---|---|
| HeartPhone Intervention | Experimental | Behavioral: HeartPhone app, Drug: Acetylcholine, Drug: Sodium Nitroprusside, Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl EsterParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartPhone appEvaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) | Behavioural | HeartPhone Intervention |
| AcetylcholineEndothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter | Drug | HeartPhone Intervention |
| Sodium NitroprussideEndothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor | Drug | HeartPhone Intervention |
| L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl EsterThis nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine. | Drug | HeartPhone Intervention |
Primary outcome
Installation of the Heartphone Application.
Time frame: 3 months
Change in the total physical activity volume from baseline to 3 months as measured by the Actigraph GT3XP-BTLE (total activity counts)
Installation of the Heartphone Application.
Time frame: 6 months
Change in the total physical activity volume from baseline to 3 and 6 month as measured by the Actigraph GT3XP-BTLE (total activity counts).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HeartPhone app, Acetylcholine and Sodium Nitroprusside in people with Breast Cancer and Leukemia, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Installation of the Heartphone Application. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.