Clinical trial NCT02659358: Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced cancer patients

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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced solid malignancy (Stage 3 or 4) with measurable disease, who are being followed by an oncologist
* 18 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

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
timeFrame: 15 days
measure: Performance status as measured with with Eastern Cooperative Oncology Group performance status (ECOG-PS) scale
timeFrame: 15 days
measure: Performance status as measured with Karnofsky Performance Status (KPS)
timeFrame: 15 days
measure: Patient-reported physical function summary using NIH Patient Reported Outcome Measurement System (PROMIS®) tool
timeFrame: 15 days
Secondary outcomes:
measure: Summary score of emotional distress as measured using NIH PROMIS® questionnaire
timeFrame: 15 days
measure: Summary score of pain interference as measured using NIH PROMIS® questionnaire
timeFrame: 15 days
measure: Summary score of fatigue as measured using NIH PROMIS® questionnaire
timeFrame: 15 days
measure: Summary score of sleep interference as measured using NIH PROMIS® questionnaire
timeFrame: 15 days
measure: Presence of frailty phenotype
timeFrame: 15 days
measure: Feasibility defined as proportion of time Fitbit is worn during study period (4 of 7 days worn in the study)
timeFrame: 15 days
measure: Occurrence of any chemotoxicity (using CTCAE v4) within patients who are undergoing treatment for their condition during time of study
timeFrame: 4 weeks after completion of study
measure: Occurrence of hospitalization (yes/no)
timeFrame: At 3 and 6 months after completion of 15 day study
measure: Number of hospitalizations
timeFrame: At 3 and 6 months after completion of 15 day study
measure: Mortality
timeFrame: At 3 and 6 months after completion of 15 day study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinal Medical Center
name: Arvind Shinde, MD
role: PRINCIPAL_INVESTIGATOR
References: