Breast Cancer, Leukemia, Lymphoma
Conditions
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.
Interventions
BEHAVIORALHeartPhone app
Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen)
DRUGAcetylcholine
Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter
DRUGSodium Nitroprusside
Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor
DRUGL-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester
This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine.
Sponsors
Penn State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-group pre-post change
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Installation of the Heartphone Application. | 3 months | Change in the total physical activity volume from baseline to 3 months as measured by the Actigraph GT3XP-BTLE (total activity counts) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Device-based physical activity volume | 401977.9 Total activity counts (vector magnitude) STANDARD_DEVIATION 37898.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
None listed