Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"

Официальное название

"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"

Обзор

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.

Подробное описание

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.

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.

ARM IV (CANCER SURVIVORS THAT ARE CURRENT/FORMER SMOKERS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a carbon monoxide (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.

PANCREATIC CANCER STUDY (PCS): 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.

Technological Approach to Performance Status (TAPS) Study: 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.

Вмешательства

• Поведенческое Exercise Intervention
  Participate in walking and/or strengthening program
• Другое Health Telemonitoring
  Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
• Другое Health Telemonitoring
  Use accelerometers, blood pressure monitor, weight scale, and smart phone
• Другое Health Telemonitoring
  Use smart phone
• Другое Health Telemonitoring
  Use CO monitor and smart phone
• Другое Health Telemonitoring
  Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies
• Другое Health Telemonitoring
  Use Fitbit and Actigraph

Первичные конечные точки

• Study completion (defined as completing the final assessment) [Срок оценки: Up to 7 months after baseline]
• Physical Activity (PA) Assessment [Срок оценки: Up to 7 days]
• ECOG Performance Status [Срок оценки: Up to 2 weeks]

Вторичные конечные точки (10)

• Correlation between PA data from the Actigraph and Fitbit [Срок оценки: Up to 7 days]
• Correlation between patients' ECOG performance status scores and PA data [Срок оценки: Up to 7 days]
• Correlation between PA data and Overall Survivor (OS) [Срок оценки: Up to 7 days]
• Accrual of Diverse Sample of Cancer-Patients [Срок оценки: Up to 2 weeks]
• Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants. [Срок оценки: Up to 2 weeks]
• Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants. [Срок оценки: Up to 2 weeks]
• Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to 2 weeks]
• 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). [Срок оценки: Up to 2 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT01365169 · 2010-0955 · NCI-2014-02468 · 2010-0955 · R01CA243554 · RC2CA148263 · R01CA177996

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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