Breast CancerNCT03054025
Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors
A study testing Smart Phone Monitoring Device in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Smart Phone Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2015to 17 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Facilitating Motivational Readiness and Adoption of Physical Activity by Breast Cancer Survivors With a Smart Phone Application
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Cancer
- Being tested
- Smart Phone Monitoring Device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Phone Monitoring DeviceDevice
Also called Monitor
Use activity tracker application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smart Phone Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start2 Sep 2015
- Primary completion31 Aug 2016
- Study completion17 May 2018
Why it stopped: funding discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Barsevick, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054025
- Sponsor's protocol ID
- 15G.393
- Other IDs
- JT 7946
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2017
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Motivational Readiness and Adoption of Physical Activity by Breast Cancer Survivors With a Smart Phone Application
- ClinicalTrials.gov ID
- NCT03054025
- Acronym / sponsor ID
- 15G.393
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding discontinued
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (smart phone application) | Experimental | Device: Smart Phone Monitoring DeviceParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Phone Monitoring DeviceAlso: MonitorUse activity tracker application | Device | Supportive care (smart phone application) |
Primary outcome
Features of the mobile application that were most used by participants
Time frame: 3 weeks
Descriptive statistics using proportions and 90% confidence intervals will be calculated for various features.
Results and safety
The study was stopped early (reason given: funding discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Barsevick, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Phone Monitoring Device in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding discontinued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Features of the mobile application that were most used by participants (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.