Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

Completed

• Conditions: Breast Cancer; Physical Activity
• Interventions: Device: Fitbit

• Registration Number: NCT03041545
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-08
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fitbit	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.

Primary Outcome Measures

Name	Time	Method
Recruitment	06/01/2015-06/01/2018	Enrolling \>20% of eligible patients

Secondary Outcome Measures

Name	Time	Method
Retention	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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States