NeoplasmsNCT02659358
Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer
An observational study of Neoplasms, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Fitbit Charge HR®
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2016to 24 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced cancer patients
Who may be able to join
- 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
Who cannot join
- Allergy to surgical steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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
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.
Read the 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
- Being tested
- Fitbit Charge HR®
- 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)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Charge HR®Device
Also called Biosensor, Activity monitor
A wrist worn biosensor, the Fitbit Charge HR® has sensor capability, good battery life, water resistant, Bluetooth capabilities, and provides accessible data.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fitbit Charge HR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 15 days
Secondary outcomes (10)
Summary score of emotional distress as measured using NIH PROMIS® questionnaire
Measured: 15 days
Summary score of pain interference as measured using NIH PROMIS® questionnaire
Measured: 15 days
Summary score of fatigue as measured using NIH PROMIS® questionnaire
Measured: 15 days
Summary score of sleep interference as measured using NIH PROMIS® questionnaire
Measured: 15 days
Presence of frailty phenotype
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.
Measured: 15 days
Feasibility defined as proportion of time Fitbit is worn during study period (4 of 7 days worn in the study)
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.
Measured: 15 days
Occurrence of any chemotoxicity (using CTCAE v4) within patients who are undergoing treatment for their condition during time 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.
Measured: 4 weeks after completion of study
Occurrence of hospitalization (yes/no)
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.
Measured: At 3 and 6 months after completion of 15 day study
Number of hospitalizations
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.
Measured: At 3 and 6 months after completion of 15 day study
Mortality
Determine whether baseline activity levels as measured using biosensor predict occurrence of death within the specified time frame
Measured: At 3 and 6 months after completion of 15 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start24 Jan 2016
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvind Shinde, Cedars-Sinai Medical Center
- Investigators
- Arvind Shinde, MD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659358
- Sponsor's protocol ID
- IIT2015-10-Shinde-Biosens
- Status last verified
- Sep 2017
- First submitted
- 14 Jan 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02659358
- Acronym / sponsor ID
- IIT2015-10-Shinde-Biosens
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 24 Jan 2016 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biosensor + Patient Reported Outcomes (PRO) | – | Device: Fitbit Charge HR®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced cancer patients
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Allergy to surgical steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Charge HR®Also: Biosensor, Activity monitorA wrist worn biosensor, the Fitbit Charge HR® has sensor capability, good battery life, water resistant, Bluetooth capabilities, and provides accessible data. | Device | Biosensor + Patient Reported Outcomes (PRO) |
Primary outcome
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)
10 secondary outcomes
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
Feasibility defined as proportion of time Fitbit is worn during study period (4 of 7 days worn in the study)
Time frame: 15 days
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
Occurrence of hospitalization (yes/no)
Time frame: At 3 and 6 months after completion of 15 day study
Number of hospitalizations
Time frame: At 3 and 6 months after completion of 15 day study
Mortality
Time frame: At 3 and 6 months after completion of 15 day study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvind Shinde, MD principal investigator
Cedars-Sinal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.