HeartPhone Cancer Survivors Trial 2019

The Pennsylvania State University (PENNSTATE)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer; Lymphoma; Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03953326

00011271

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

HeartPhone Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: HeartPhone app

Drug: Sodium Nitroprusside

Drug: Acetylcholine

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