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

NCT02659358 | Completed

• 1 other identifier: IIT2015-10-Shinde-Biosens
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Keywords

Advanced solid malignancy; Activity monitor; Biosensor; Fitbit; Patient Reported Outcomes (PRO); Stage 3/4 cancer; Performance Status; Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

Outcome Measures

Primary Outcomes (4)

• Physical activity as measured using Fitbit Charge HR (composite of mean daily steps and stairs per day, mean resting heart rate, mean daily active minutes and time sedentary, stairs climbed)

  Data will be compared to reference standards to answer primary objective.

  15 days

• Performance status as measured with with Eastern Cooperative Oncology Group performance status (ECOG-PS) scale

  ECOG PS will be compared to physical activity as measured using biosensor data (Outcome 1)

  15 days

• Performance status as measured with Karnofsky Performance Status (KPS)

  KPS will be compared to physical activity as measured using biosensor data (Outcome 1)

  15 days

• Patient-reported physical function summary using NIH Patient Reported Outcome Measurement System (PROMIS®) tool

  Mean weekly summary score of physical function from NIH PROMIS® tools will be compared to biosensor metrics (outcome 1) and performance status (Outcomes 2 and 3)

  15 days

Secondary Outcomes (10)

• Summary score of emotional distress as measured using NIH PROMIS® questionnaire

  15 days

• Summary score of pain interference as measured using NIH PROMIS® questionnaire

  15 days

• Summary score of fatigue as measured using NIH PROMIS® questionnaire

  15 days

• Summary score of sleep interference as measured using NIH PROMIS® questionnaire

  15 days

• Presence of frailty phenotype

  15 days

Study Arms (1)

Biosensor + Patient Reported Outcomes (PRO)

Participants will wear a biosensor (Fitbit Charge HR®) continuously for a period of 15 days and respond to PROMIS questionnaires. This is not a chemotherapy or treatment-intervention trial.

Device: Fitbit Charge HR®

Interventions

Fitbit Charge HR® DEVICE

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

Also known as: Biosensor, Activity monitor

Biosensor + Patient Reported Outcomes (PRO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced cancer patients

You may qualify if:

• Diagnosis of advanced solid malignancy (Stage 3 or 4) with measurable disease, who are being followed by an oncologist
• years or older
• English speaking
• Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
• Access to IOS or Android smartphone with internet access
• Expected to have oncology clinic visits at least once every 2 weeks
• Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
• Ability to consent

You may not qualify if:

• Allergy to surgical steel or elastomer/rubber
• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Biosensing Techniques; Fitness Trackers

Intervention Hierarchy (Ancestors)

Molecular Probe Techniques; Investigative Techniques; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Arvind Shinde, MD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Physician

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: January 24, 2016
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)