Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Physical Activity
• Intervention / Treatment: Device: Fitbit

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Fitbit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Enrolling >20% of eligible patients	06/01/2015-06/01/2018

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sheri J Hartman, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): February 8, 2018
• Study Completion (Actual): February 8, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 150860; 5U54CA155435-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No