Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT02659358|
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : September 25, 2017
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.
|Condition or disease||Intervention/treatment|
|Neoplasms||Device: Fitbit Charge HR®|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||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|
|Actual Study Start Date :||January 24, 2016|
|Actual Primary Completion Date :||August 24, 2017|
|Actual Study Completion Date :||August 24, 2017|
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®
A wrist worn biosensor, the Fitbit Charge HR® has sensor capability, good battery life, water resistant, Bluetooth capabilities, and provides accessible data.
- 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) [ Time Frame: 15 days ]Data will be compared to reference standards to answer primary objective.
- Performance status as measured with with Eastern Cooperative Oncology Group performance status (ECOG-PS) scale [ Time Frame: 15 days ]ECOG PS will be compared to physical activity as measured using biosensor data (Outcome 1)
- Performance status as measured with Karnofsky Performance Status (KPS) [ Time Frame: 15 days ]KPS will be compared to physical activity as measured using biosensor data (Outcome 1)
- Patient-reported physical function summary using NIH Patient Reported Outcome Measurement System (PROMIS®) tool [ Time Frame: 15 days ]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)
- Summary score of emotional distress as measured using NIH PROMIS® questionnaire [ Time Frame: 15 days ]
- Summary score of pain interference as measured using NIH PROMIS® questionnaire [ Time Frame: 15 days ]
- Summary score of fatigue as measured using NIH PROMIS® questionnaire [ Time Frame: 15 days ]
- Summary score of sleep interference as measured using NIH PROMIS® questionnaire [ Time Frame: 15 days ]
- Presence of frailty phenotype [ Time Frame: 15 days ]Using Fried's definition, frailty is present if ≥3 characteristics of frailty are present. Association between measures of frailty and biosensor data will be measured.
- Feasibility defined as proportion of time Fitbit is worn during study period (4 of 7 days worn in the study) [ Time Frame: 15 days ]This will be measured by using the duration of time that the Fitbit Charge HR is worn and recording data during the study. Recorded data from the device for 4 of each 7 days of the study (at least 16 hrs of each day) will support feasibility of utilizing the Fitbit Charge HR to collect data. Feasibility of collecting PROMIS® tool responses will be determined by percentage of completed PROMIS® tools. PROMIS® tool completion rates of >50% will support the feasibility of current method of utilizing PROMIS® tools to collect PROs.
- Occurrence of any chemotoxicity (using CTCAE v4) within patients who are undergoing treatment for their condition during time of study [ Time Frame: 4 weeks after completion of study ]Patients enrolling in the study will be treated for their condition (per standard of care). We will capture the occurrence of toxicities form their respective treatments to determine how physical activity (as measured using the biosensor) predicts the events.
- Occurrence of hospitalization (yes/no) [ Time Frame: At 3 and 6 months after completion of 15 day study ]Will follow-up with patients at specified time points to determine whether the patient experienced any hospitalizations (binary event) to determine whether baseline activity levels (as measured using biosensor) predicts the event.
- Number of hospitalizations [ Time Frame: At 3 and 6 months after completion of 15 day study ]Will follow-up with patients at specified time points to determine how many hospitalizations the patient experienced (continuous) to evaluate whether baseline activity levels (as measured using biosensor) predicts the number of hospitalizations.
- Mortality [ Time Frame: At 3 and 6 months after completion of 15 day study ]Determine whether baseline activity levels as measured using biosensor predict occurrence of death within the specified time frame
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): NCT02659358
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Arvind Shinde, MD||Cedars-Sinal Medical Center|