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HeartPhone Cancer Survivors Trial 2019

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953326
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
David E Conroy, Penn State University

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE April 23, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Physical activity volume [ Time Frame: 3 month ]
Daily step counts over 1-week from Fitbit device
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Microvessel function [ Time Frame: 3 month ]
Skin blood flow during perfusion of endothelium-dependent and independent agonists
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HeartPhone Cancer Survivors Trial 2019
Official Title  ICMJE Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single-group pre-post change
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Cancer
  • Leukemia
  • Lymphoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Behavioral: HeartPhone app
  • Drug: Acetylcholine
  • Drug: Sodium Nitroprusside
  • Drug: L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David E Conroy, PhD 814-865-3451 conroy@psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953326
Other Study ID Numbers  ICMJE 00011271
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David E Conroy, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Penn State University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP