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Clinical Trials/NCT03953326
NCT03953326
Terminated
Phase 1

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

Penn State University1 site in 1 country3 target enrollmentApril 23, 2019

Overview

Phase
Phase 1
Intervention
HeartPhone app
Conditions
Breast Cancer
Sponsor
Penn State University
Enrollment
3
Locations
1
Primary Endpoint
Physical activity volume
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2019
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David E Conroy

Professor

Penn State University

Eligibility 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

Arms & Interventions

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.

Intervention: HeartPhone app

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.

Intervention: Acetylcholine

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.

Intervention: Sodium Nitroprusside

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.

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

Outcomes

Primary Outcomes

Physical activity volume

Time Frame: 3 month

Daily step counts over 1-week from Fitbit device

Secondary Outcomes

  • Microvessel function(3 month)

Study Sites (1)

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