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OpenTrials
Completed

NCT Number: NCT03041545

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.

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Key information

Age range

21 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit

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.

Primary outcomes

  1. Recruitment

    Time frame: 06/01/2015-06/01/2018

    Enrolling >20% of eligible patients

Secondary outcomes

  1. Retention

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2017
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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