Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041545
• Other study ID #: 150860
• Secondary ID: 5U54CA155435-05
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: February 8, 2018

Study information

• Verified date: June 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Enrolling >20% of eligible patients	06/01/2015-06/01/2018
Secondary	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.