NCT02659358

Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer

The Biosensor Study: Exploratory Study Evaluating the Use of Wearable Biosensors and Patient Reported Outcomes (PROs) to Assess Performance Status and Distress in Patients With Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the association between wearable biosensor data, performance status and patient-reported outcomes in cancer patients. Participants in this study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires that will assess patient reported outcome measures including physical function, emotional distress, pain interference, sleep disturbance and fatigue. Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18 years of age and be English speaking due to the questionnaires that will be administered during the study. Patients must also be ambulatory (use of walking aids, such as cane and rollator, is acceptable) and have access to a smartphone with internet access (IOS or Android). It is also necessary for patients to have scheduled oncology clinic visits at least once every 2 weeks.

Detailed description

This study aims to measure association between biosensor data, performance status and patient-reported outcomes. This study will also evaluate the feasibility of using Fitbit activity monitors in a cancer population to capture objective activity data. The study will be recruiting patients with advanced cancer diagnoses (stage 3 or 4) and will be referred by the treating oncologist. This is an exploratory study that will follow patients with stage 3-4 cancer for a period of 15 days. Subjects will be provided with a Fitbt Charge HR® activity monitor. They will be requested to wear the Fitbit Charge HR® at all times, except for while bathing or performing other activities where the activity monitor can become submerged in water. Subjects will be asked to wear the Fitbit Charge HR® for two weeks. They will be seen in the clinic at baseline, at the end of week 1 (day 8) and at end of 2 weeks (day 15) for physical exam, evaluation of performance status by both treating oncologist and practice nurse using standardized scales and administration of PROMIS® questionnaires. Patients will be followed up to 6 months after the last clinic visit for adverse events, hospitalization and survival. Thirty subjects will be enrolled in this study.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DEVICE	Fitbit Charge HR®	A wrist worn biosensor, the Fitbit Charge HR® has sensor capability, good battery life, water resistant, Bluetooth capabilities, and provides accessible data.

Timeline

• Start date: 2016-01-24
• Primary completion: 2017-08-24
• Completion: 2017-08-24
• First posted: 2016-01-20
• Last updated: 2017-09-25

Locations

1 site across 1 country: United States