Evaluating the Use of Wearable Biosensors and PROs to Assess Performance Status in Patients With Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/10/2017 |
| Start Date: | January 2016 |
| End Date: | December 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Arvind Shinde, MD
Phone: 310-423-5651
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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