"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- Physical Activity (PA) Assessment
研究概览
简要总结
The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.
详细描述
PRIMARY OBJECTIVES:
I. To explore the feasibility and acceptability in diverse samples of cancer patients of wireless collection and transmission of data for transfer into the open-source cyberinfrastructure (CI) called Cyberinfrastructure for Comparative Effectiveness Research (CYCORE).
OUTLINE: Patients are assigned to 1 of 4 arms.
ARM I (COLORECTAL CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a global positioning system (GPS) device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
ARM II (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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 any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1)
- •Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4)
- •Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study)
- •Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)
- •Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1)
- •Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3)
- •History of any cancer, other than non-melanoma skin cancer (Arm 4)
- •Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4)
- •Has a valid home address and functioning home telephone number (Arm 4)
- •Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4)
- •Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)
- •Fluent in English (PCS study)
- •Must have telephone access and agree to engage with research personnel using telephone (PCS study)
- •Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study)
- •Fluent in English (TAPS study)
- •Age 18 years or older (TAPS study)
- •ECOG performance status score between 0-3 (TAPS study)
排除标准
- •Major surgery in the past 8 weeks (Arms 1 and 4)
- •Self-reports hypertension that is not being monitored by a physician and is not being managed with either medication, observation, or lifestyle change (Pre-pilot phase, Arms 1-3)
- •Overt cognitive difficulty demonstrated by not being clearly oriented to time or person or place (Arms 1-4)
- •Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2)
- •Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3)
- •Zubrod performance status > 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3)
- •Currently receiving treatment for a cancer other than those listed in the arm-specific inclusion criteria (exception: the study does not exclude those receiving treatment for non-melanoma skin cancer) (Arms 2 and 3)
- •History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only)
- •Active substance use disorder (diagnosed or strongly suspected) (Arm 4)
- •Currently enrolled in protocol 2014-0712 (PCS study)
- •No home access to internet (PCS study)
- •No home WiFi connection (PCS study)
- •During clinician's pre-surgical evaluation, presents with high risk for non-therapeutic resection related to cancer diagnosis (PCS study)
- •Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
- •Recent fracture or acute musculoskeletal injury that precludes the ability to fully bear weight on all 4 limbs in order to participate in an exercise intervention (PCS study)
- •Poorly-controlled pain with a self-reported pain score of 7/10 at the time of enrollment (PCS study)
- •Myopathic or rheumatologic disease that impacts physical function (PCS study)
- •Has a pacemaker or other internal medical device, or reports being pregnant (PCS study)
- •Currently enrolled in protocol 2017-0198 (PCS study)
- •Demonstration of overt cognitive difficulty as demonstrated by not being clearly oriented to time or person or place (TAPS study)
研究组 & 干预措施
Arm IV (cancer survivors that are current/former smokers)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a CO monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
干预措施: Health Telemonitoring (Other)
Arm IV (cancer survivors that are current/former smokers)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a CO monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
干预措施: Questionnaire Administration (Other)
TAPS (Technological Approach to Performance Status)
Patients use two Physical Activity monitor devices, the wrist-worn device (Fitbit) continuously and the Actigraph during waking hours. Patients use the devices for 7 consecutive days.
干预措施: Health Telemonitoring (Other)
Arm I (colorectal cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a GPS device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
干预措施: Health Telemonitoring (Other)
Arm I (colorectal cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a GPS device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
干预措施: Questionnaire Administration (Other)
Arm II (head and neck cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
干预措施: Health Telemonitoring (Other)
Arm II (head and neck cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days.
干预措施: Questionnaire Administration (Other)
Arm III (head and neck cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days.
干预措施: Health Telemonitoring (Other)
Arm III (head and neck cancer patients)
(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days.
干预措施: Questionnaire Administration (Other)
PCS (pancreatic surgery patients)
Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.
干预措施: Exercise Intervention (Behavioral)
PCS (pancreatic surgery patients)
Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.
干预措施: Health Telemonitoring (Other)
PCS (pancreatic surgery patients)
Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.
干预措施: Quality-of-Life Assessment (Other)
PCS (pancreatic surgery patients)
Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Physical Activity (PA) Assessment
时间窗: Up to 7 days
PA will be measured by two different devices, (1) a consumer-grade wrist-worn device that collects continuous PA data (Fitbit), and (2) a research-grade, hip-worn accelerometer (Actigraph)
ECOG Performance Status
时间窗: Up to 2 weeks
Eastern Cooperation Oncology Group (ECOG) is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.
Study completion (defined as completing the final assessment)
时间窗: Up to 7 months after baseline
次要结局
- Accrual of Diverse Sample of Cancer-Patients(Up to 2 weeks)
- Correlation between patients' ECOG performance status scores and PA data(Up to 7 days)
- Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.(Up to 2 weeks)
- Successful upload of data from the home-based health monitor devices to the Cyberinfrastructure for Comparative effectiveness Research (CYCORE) for future analysis.(Up to 2 weeks)
- Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.(Up to 2 weeks)
- Adherence to procedures for home-based health monitor devices activation (e.g. Fitbit, Actigraph, CO monitor, weight scales) self-monitoring (e.g. PA, weight), and self-reported data capture by the devices.(Up to 2 weeks)
- Correlation between PA data from the Actigraph and Fitbit(Up to 7 days)
- Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).(Up to 2 weeks)
- Correlation between PA data and Overall Survivor (OS)(Up to 7 days)
- CYCORE Data availability for clinicians and researchers in order to be able to daily monitor patients using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).(Up to 2 weeks)