Tracking Physical Activity Throughout Chemotherapy for Breast Cancer
2 other identifiers
observational
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2018
CompletedJune 12, 2018
June 1, 2018
2.7 years
January 30, 2017
June 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Recruitment
Enrolling \>20% of eligible patients
06/01/2015-06/01/2018
Secondary Outcomes (1)
Retention
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.
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
The study population is all women approached to attempt recruitment. Women will be recruited through the Medical Oncology Clinics at UCSD Moroes Cancer Center.
You may qualify if:
- 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
You may not qualify if:
- Serious physical limitation that greatly limits mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheri J Hartman, PhD
Assistant Professor
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 30, 2017
First Posted
February 2, 2017
Study Start
June 1, 2015
Primary Completion
February 8, 2018
Study Completion
February 8, 2018
Last Updated
June 12, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share