Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart Phone Monitoring Device
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- A participant is only able to participate in one phase, not both phases, of the research study
- Must have completed breast cancer treatment
- Those on adjuvant hormonal therapy are allowed to participate in the research study (either phase)
Exclusion Criteria:
- Those who currently meet the Centers for Disease Control and Prevention (CDC)'s physical activity guidelines
- Those who do not currently use a smartphone (of any kind)
- Those who do not read and speak English
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (smart phone application)
Arm Description
Participants download the physical activity readiness smart phone application onto their personal smartphone and receive training on how to use the app which includes animated video clips, tailored email reminders, and feedback on progress for 3 weeks.
Outcomes
Primary Outcome Measures
Features of the mobile application that were most used by participants
Descriptive statistics using proportions and 90% confidence intervals will be calculated for various features.
Secondary Outcome Measures
Full Information
NCT ID
NCT03054025
First Posted
January 31, 2017
Last Updated
October 29, 2019
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03054025
Brief Title
Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors
Official Title
Facilitating Motivational Readiness and Adoption of Physical Activity by Breast Cancer Survivors With a Smart Phone Application
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
funding discontinued
Study Start Date
September 2, 2015 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
May 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot clinical trial studies how well a smart phone application works in increasing physical activity in breast cancer survivors. A smart phone application that increases physical activity may help reduce the likelihood of cancer coming back in breast cancer survivors.
Detailed Description
PRIMARY OBJECTIVES:
I. To conduct a pilot study to inform the design of a mobile health application for smartphone that is targeted to increase physical activity and reduce risks associated with breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (smart phone application)
Arm Type
Experimental
Arm Description
Participants download the physical activity readiness smart phone application onto their personal smartphone and receive training on how to use the app which includes animated video clips, tailored email reminders, and feedback on progress for 3 weeks.
Intervention Type
Device
Intervention Name(s)
Smart Phone Monitoring Device
Other Intervention Name(s)
Monitor
Intervention Description
Use activity tracker application
Primary Outcome Measure Information:
Title
Features of the mobile application that were most used by participants
Description
Descriptive statistics using proportions and 90% confidence intervals will be calculated for various features.
Time Frame
3 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A participant is only able to participate in one phase, not both phases, of the research study
Must have completed breast cancer treatment
Those on adjuvant hormonal therapy are allowed to participate in the research study (either phase)
Exclusion Criteria:
Those who currently meet the Centers for Disease Control and Prevention (CDC)'s physical activity guidelines
Those who do not currently use a smartphone (of any kind)
Those who do not read and speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Barsevick, PhD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors
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