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Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041545
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sheri Hartman, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Physical Activity 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 Design
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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment [ Time Frame: 06/01/2015-06/01/2018 ]
    Enrolling >20% of eligible patients


Secondary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041545


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sheri J Hartman, PhD Assistant Professor
More Information
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Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03041545    
Other Study ID Numbers: 150860
5U54CA155435-05 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases