Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

NCT ID: NCT03041545

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2018-02-08

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.

Conditions

Breast Cancer; Physical Activity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Fitbit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sheri Hartman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheri J Hartman, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

5U54CA155435-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

150860

Identifier Type: -

Identifier Source: org_study_id