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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54CA155435-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Physical activity during chemotherapy has been shown to increase patient health and wellbeing as well as improve outcomes in breast cancer patients. The primary aim of this project is to determine the feasibility of incorporating wearable sensors into clinical care by having breast cancer patients, undergoing chemotherapy, wear a commercially available monitor (Fitbit) that tracks physical activity, sleep, and heart rate monitor.
Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. Existing research has primarily relied on self-reported activity levels and only captured periodic snap shots or retrospective reports of activity levels, which are subject to recall bias. Exactly how activity levels change throughout chemotherapy is not known. This study will provide minute-by-minute level objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent declines in physical activity.
The investigators will assess the feasibility of the pre-treatment recruitment by documenting recruitment rates and participant acceptance of wearing the accelerometer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitbit | All participants will be asked to wear the Fitbit as much as possible and to sync it at least once a week, from one week prior to start of chemotherapy treatment to six months after ending chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit | Device | Women enrolled in the study will be asked to wear a Fitbit from one week prior to chemotherapy until six months post-chemotherapy. The Fitbit is a watch-sized, wrist worn, physical activity tracker. A button, when pressed, displays the wearer's accumulated daily steps, mileage, and steps climbed. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Enrolling >20% of eligible patients | 06/01/2015-06/01/2018 |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | >80% of participants wore the Fitbit for >80% of the days during chemotherapy treatment | From date enrolled into the study until 1 week after the date of the last infusion center visit for chemotherapy, which is typically up to 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
• Serious physical limitation that greatly limits mobility
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The study population is all women approached to attempt recruitment. Women will be recruited through the Medical Oncology Clinics at UCSD Moroes Cancer Center.
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| Name | Affiliation | Role |
|---|---|---|
| Sheri J Hartman, PhD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |