Breast CancerNCT01837147
Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)
A study testing Technology-Based Physical Activity Promotion and Pedometer Intervention in people with Breast Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Technology-Based Physical Activity Promotion and Pedometer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2014
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Postmenopausal
- BMI >= 25.0 kg/m2
- Physically inactive
- Internet user with regular access to high-speed internet
- Willing and able to complete study requirements
Who cannot join
- History of invasive breast cancer
- Medical contraindication to exercise
- Medical problem or other issue that would interfere with intervention
- Current participation in another physical activity study
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093
About this study
Official title: Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk
Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.
- Conditions
- Breast Cancer
- Being tested
- Technology-Based Physical Activity Promotion, Pedometer Intervention
- Keywords
- primary prevention, sedentary, overweight, obesity, breast cancer, post-menopausal, women
- Medical subject headings
- Breast Neoplasms, Sedentary Behavior, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Based Physical Activity PromotionBehavioural
Participants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels.
Pedometer InterventionBehavioural
Participants assigned to this group will receive a pedometer and be trained in its use.
| Study group | Role | What they receive |
|---|---|---|
| Web-based Tracking Group | Experimental | Technology-Based Physical Activity Promotion Receives: Behavioral: Technology-Based Physical Activity Promotion |
| Pedometer Group | Active comparator | Participants assigned to this group will receive a pedometer. Receives: Behavioral: Pedometer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objectively-measured physical activity
Assessed using ActiGraph.
Measured: Baseline to 16 weeks
Secondary outcomes (4)
Self-reported physical activity
Assessed using questionnaires.
Measured: Baseline to 16 weeks
Body weight (kg)
Measured in clinic.
Measured: Baseline to 16 weeks
Uptake of technology-based intervention components
To be assessed via data downloaded from the website used in this study.
Measured: During 16-week intervention
Quality of life
To be assessed via self-report questionnaire.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa A Cadmus-Bertram, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837147
- Sponsor's protocol ID
- 1R03CA168450-01
- Status last verified
- Feb 2020
- First submitted
- 6 Apr 2013
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Cadmus-Bertram L, Marcus BH, Patterson RE, Parker BA, Morey BL. Use of the Fitbit to Measure Adherence to a Physical Activity Intervention Among Overweight or Obese, Postmenopausal Women: Self-Monitoring Trajectory During 16 Weeks. JMIR Mhealth Uhealth. 2015 Nov 19;3(4):e96. doi: 10.2196/mhealth.4229.
PubMed 26586418Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.
PubMed 26071863
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT01837147
- Acronym / sponsor ID
- 1R03CA168450-01
- Conditions
- Breast Cancer
- Keywords
- primary prevention, sedentary, overweight, obesity, breast cancer, post-menopausal, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Apr 2013 (estimated)
- 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.
Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based Tracking Group | Experimental | Behavioral: Technology-Based Physical Activity PromotionTechnology-Based Physical Activity Promotion |
| Pedometer Group | Active comparator | Behavioral: Pedometer InterventionParticipants assigned to this group will receive a pedometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Postmenopausal
- BMI >= 25.0 kg/m2
- Physically inactive
- Internet user with regular access to high-speed internet
Key exclusion criteria (4 listed)
- History of invasive breast cancer
- Medical contraindication to exercise
- Medical problem or other issue that would interfere with intervention
- Current participation in another physical activity study
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 |
|---|---|---|
| Technology-Based Physical Activity PromotionParticipants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels. | Behavioural | Web-based Tracking Group |
| Pedometer InterventionParticipants assigned to this group will receive a pedometer and be trained in its use. | Behavioural | Pedometer Group |
Primary outcome
Change in objectively-measured physical activity
Time frame: Baseline to 16 weeks
Assessed using ActiGraph.
4 secondary outcomes
Self-reported physical activity
Time frame: Baseline to 16 weeks
Body weight (kg)
Time frame: Baseline to 16 weeks
Uptake of technology-based intervention components
Time frame: During 16-week intervention
Quality of life
Time frame: Baseline to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 26586418Cadmus-Bertram L, Marcus BH, Patterson RE, Parker BA, Morey BL. Use of the Fitbit to Measure Adherence to a Physical Activity Intervention Among Overweight or Obese, Postmenopausal Women: Self-Monitoring Trajectory During 16 Weeks. JMIR Mhealth Uhealth. 2015 Nov 19;3(4):e96. doi: 10.2196/mhealth.4229.
- Derived from this study: PubMed 26071863Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.
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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.
Lisa A Cadmus-Bertram, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Based Physical Activity Promotion and Pedometer Intervention in people with Breast Cancer, run by University of California, San Diego 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 7 Feb 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in objectively-measured physical activity (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837147, which also lists 2 linked publications.
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 7 Feb 2020.