HeartPhone Cancer Survivors Trial 2019

Breast Cancer Clinical Trial

Official title:

Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03953326
• Other study ID #: 00011271
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 23, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Leukemia
• Lymphoma

Intervention

Behavioral:
• HeartPhone app
Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen)

Drug:
• 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.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity volume	Daily step counts over 1-week from Fitbit device	3 month
Secondary	Microvessel function	Skin blood flow during perfusion of endothelium-dependent and independent agonists	3 month