Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03041545|
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment|
|Breast Cancer Physical Activity||Device: Fitbit|
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.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Tracking Physical Activity Throughout Chemotherapy for Breast Cancer|
|Actual Study Start Date :||June 1, 2015|
|Actual Primary Completion Date :||February 8, 2018|
|Actual Study Completion Date :||February 8, 2018|
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.
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.
- Recruitment [ Time Frame: 06/01/2015-06/01/2018 ]Enrolling >20% of eligible patients
- Retention [ Time Frame: 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. ]>80% of participants wore the Fitbit for >80% of the days during chemotherapy treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041545
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Sheri J Hartman, PhD||Assistant Professor|