Clinical trial NCT03041545: Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
Official title: Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Physical Activity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-02
Enrollment: 32
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all women approached to attempt recruitment. Women will be recruited through the Medical Oncology Clinics at UCSD Moroes Cancer Center.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female
* Diagnosed with breast cancer
* Scheduled to receive chemotherapy, but has not yet started chemotherapy
* Receiving chemotherapy at a University of California, San Diego clinic
* Willingness to wear the Fitbit throughout the course of chemotherapy
* Access to a computer or Bluetooth enabled phone to sync Fitbit data
* Able to read and communicate in English

Exclusion Criteria:

• Serious physical limitation that greatly limits mobility

Primary outcomes:
measure: Recruitment
timeFrame: 06/01/2015-06/01/2018
Secondary outcomes:
measure: Retention
timeFrame: 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.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: Assistant Professor
name: Sheri J Hartman, PhD
role: PRINCIPAL_INVESTIGATOR
References: