Smart Phone Application in Increasing Physical Activity i... | NCT03054025

Studies
Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors

NCT03054025

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Status

Terminated

Last Update Posted

Apr 29, 2025Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Smart Phone Monitoring Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
JT 7946	Other Identifier	JeffTrial Number

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding discontinued

Expanded Access Info

Start Date

Sep 2, 2015Actual

Primary Completion Date

Aug 31, 2016Actual

Completion Date

May 17, 2018Actual

First Submitted Date

Jan 31, 2017

First Submission Date that Met QC Criteria

Feb 10, 2017

First Posted Date

Feb 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

Apr 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supportive care (smart phone application)	Experimental	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.	Device: Smart Phone Monitoring Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smart Phone Monitoring Device	Device	Use activity tracker application	Supportive care (smart phone application)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Barsevick, PhD	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sidney Kimmel Cancer Center at Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

References Module

Citations

Not provided

Label	URL
Sidney Kimmel Cancer Center	View source
Thomas Jefferson University Hospital	View source

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis