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HeartPhone Cancer Survivors Trial 2019

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ClinicalTrials.gov Identifier: NCT03953326
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
David E Conroy, Penn State University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Leukemia Lymphoma Behavioral: HeartPhone app Drug: Acetylcholine Drug: Sodium Nitroprusside Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single-group pre-post change
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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

Drug: Sodium Nitroprusside
Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor

Drug: 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.




Primary Outcome Measures :
  1. Physical activity volume [ Time Frame: 3 month ]
    Daily step counts over 1-week from Fitbit device


Secondary Outcome Measures :
  1. Microvessel function [ Time Frame: 3 month ]
    Skin blood flow during perfusion of endothelium-dependent and independent agonists



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953326


Contacts
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Contact: David E Conroy, PhD 814-865-3451 conroy@psu.edu

Locations
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United States, Pennsylvania
The Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: David E Conroy, PhD    814-865-3451    conroy@psu.edu   
Contact: Deborah Reese, MS    814-865-7935    dlb43@psu.edu   
Sponsors and Collaborators
Penn State University
  Study Documents (Full-Text)

Documents provided by David E Conroy, Penn State University:

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Responsible Party: David E Conroy, Professor, Penn State University
ClinicalTrials.gov Identifier: NCT03953326     History of Changes
Other Study ID Numbers: 00011271
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acetylcholine
Nitroprusside
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Nitric Oxide Donors