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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Allergy to surgical steel or elastomer/rubber
- •Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment
结局指标
主要结局
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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
次要结局
- 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)
- Feasibility defined as proportion of time Fitbit is worn during study period (4 of 7 days worn in the study)(15 days)
- Occurrence of any chemotoxicity (using CTCAE v4) within patients who are undergoing treatment for their condition during time of study(4 weeks after completion of study)
- Occurrence of hospitalization (yes/no)(At 3 and 6 months after completion of 15 day study)
- Number of hospitalizations(At 3 and 6 months after completion of 15 day study)
- Mortality(At 3 and 6 months after completion of 15 day study)
研究者
Arvind Shinde
Faculty Physician
Cedars-Sinai Medical Center