رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT01365169 لـ ورم خبيث في الرأس والعنق، ورم خبيث، Metastatic Malignant Neoplasm in the Neck، ورم خبيث نقيلي في عنق الرحم، سرطانة غدية بنكرياسية، سرطان البنكرياس العصبي الصماوي، سرطان القولون والمستقيم المتكرر، سرطان القولون والمستقيم المرحلة I AJCC v6 وv7، Stage I Hypopharyngeal Carcinoma AJCC V7، Stage I Major Salivary Gland Cancer AJCC V7، Stage I Nasopharyngeal Carcinoma AJCC V7، Stage I Oral Cavity Cancer AJCC V6 and V7، Stage I Oropharyngeal Carcinoma AJCC V6 and V7، المرحلة الثانية من سرطان القولون والمستقيم AJCC v7، Stage II Hypopharyngeal Carcinoma AJCC V6 and V7، Stage II Major Salivary Gland Cancer AJCC V7، Stage II Nasopharyngeal Carcinoma AJCC V7، Stage II Oral Cavity Cancer AJCC V6 and V7، Stage II Oropharyngeal Carcinoma AJCC V6 and V7، Stage IIA Colorectal Cancer AJCC V7، Stage IIB Colorectal Cancer AJCC V7، Stage IIC Colorectal Cancer AJCC V7، سرطان القولون والمستقيم المرحلة الثالثة AJCC الإصدار 7، Stage III Hypopharyngeal Carcinoma AJCC V7، Stage III Laryngeal Cancer AJCC V6 and V7، Stage III Major Salivary Gland Cancer AJCC V7، المرحلة III من سرطان البلعوم الأنفي AJCC v7، Stage III Oral Cavity Cancer AJCC V6 and V7، Stage III Oropharyngeal Carcinoma AJCC V7، المرحلة الثالثة أ سرطان القولون والمستقيم AJCC v7، المرحلة الثالثة ب سرطان القولون والمستقيم AJCC v7، المرحلة IIIC سرطان القولون والمستقيم AJCC v7، المرحلة IV سرطان القولون والمستقيم AJCC v7، المرحلة IVA من سرطان القولون والمستقيم AJCC v7، Stage IVA Hypopharyngeal Carcinoma AJCC V7، Stage IVA Laryngeal Cancer AJCC V7، المرحلة IVA من سرطان الغدد اللعابية الكبرى AJCC v7، المرحلة IVA من سرطان البلعوم الأنفي AJCC v7، المرحلة IVA من سرطان تجويف الفم AJCC v6 و v7، Stage IVA Oropharyngeal Carcinoma AJCC V7، المرحلة IVB من سرطان القولون والمستقيم AJCC v7، Stage IVB Hypopharyngeal Carcinoma AJCC V7، Stage IVB Laryngeal Cancer AJCC V7، المرحلة IVB من سرطان الغدد اللعابية الكبرى AJCC v7، سرطان البلعوم الأنفي المرحلة الرابعة ب AJCC v7، المرحلة IVB من سرطان تجويف الفم AJCC v6 و v7، Stage IVB Oropharyngeal Carcinoma AJCC V7، Metastatic or Locally Unresectable Solid Tumor هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
مركز إم دي أندرسون للسرطان 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"
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT01365169 هي دراسة تدخُّلية لـورم خبيث في الرأس والعنق، ورم خبيث، Metastatic Malignant Neoplasm in the Neck، ورم خبيث نقيلي في عنق الرحم، سرطانة غدية بنكرياسية، سرطان البنكرياس العصبي الصماوي، سرطان القولون والمستقيم المتكرر، سرطان القولون والمستقيم المرحلة I AJCC v6 وv7، Stage I Hypopharyngeal Carcinoma AJCC V7، Stage I Major Salivary Gland Cancer AJCC V7، Stage I Nasopharyngeal Carcinoma AJCC V7، Stage I Oral Cavity Cancer AJCC V6 and V7، Stage I Oropharyngeal Carcinoma AJCC V6 and V7، المرحلة الثانية من سرطان القولون والمستقيم AJCC v7، Stage II Hypopharyngeal Carcinoma AJCC V6 and V7، Stage II Major Salivary Gland Cancer AJCC V7، Stage II Nasopharyngeal Carcinoma AJCC V7، Stage II Oral Cavity Cancer AJCC V6 and V7، Stage II Oropharyngeal Carcinoma AJCC V6 and V7، Stage IIA Colorectal Cancer AJCC V7، Stage IIB Colorectal Cancer AJCC V7، Stage IIC Colorectal Cancer AJCC V7، سرطان القولون والمستقيم المرحلة الثالثة AJCC الإصدار 7، Stage III Hypopharyngeal Carcinoma AJCC V7، Stage III Laryngeal Cancer AJCC V6 and V7، Stage III Major Salivary Gland Cancer AJCC V7، المرحلة III من سرطان البلعوم الأنفي AJCC v7، Stage III Oral Cavity Cancer AJCC V6 and V7، Stage III Oropharyngeal Carcinoma AJCC V7، المرحلة الثالثة أ سرطان القولون والمستقيم AJCC v7، المرحلة الثالثة ب سرطان القولون والمستقيم AJCC v7، المرحلة IIIC سرطان القولون والمستقيم AJCC v7، المرحلة IV سرطان القولون والمستقيم AJCC v7، المرحلة IVA من سرطان القولون والمستقيم AJCC v7، Stage IVA Hypopharyngeal Carcinoma AJCC V7، Stage IVA Laryngeal Cancer AJCC V7، المرحلة IVA من سرطان الغدد اللعابية الكبرى AJCC v7، المرحلة IVA من سرطان البلعوم الأنفي AJCC v7، المرحلة IVA من سرطان تجويف الفم AJCC v6 و v7، Stage IVA Oropharyngeal Carcinoma AJCC V7، المرحلة IVB من سرطان القولون والمستقيم AJCC v7، Stage IVB Hypopharyngeal Carcinoma AJCC V7، Stage IVB Laryngeal Cancer AJCC V7، المرحلة IVB من سرطان الغدد اللعابية الكبرى AJCC v7، سرطان البلعوم الأنفي المرحلة الرابعة ب AJCC v7، المرحلة IVB من سرطان تجويف الفم AJCC v6 و v7، Stage IVB Oropharyngeal Carcinoma AJCC V7، Metastatic or Locally Unresectable Solid Tumor وهي قيد التجنيد. بدأت في ٢٢ جمادى الآخرة ١٤٣٢ هـ مع خطة لتجنيد ٥٩٠ مشاركًا. يقودها مركز إم دي أندرسون للسرطان ، ومن المتوقع اكتمالها بحلول ٢٥ محرم ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٩ صفر ١٤٤٧ هـ.
الملخص
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.
وصف مفصل
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.
العنوان الرسمي
"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
الحالات الطبية
ورم خبيث في الرأس والعنقورم خبيثMetastatic Malignant Neoplasm in the Neckورم خبيث نقيلي في عنق الرحمسرطانة غدية بنكرياسيةسرطان البنكرياس العصبي الصماويسرطان القولون والمستقيم المتكررسرطان القولون والمستقيم المرحلة I AJCC v6 وv7Stage I Hypopharyngeal Carcinoma AJCC V7Stage I Major Salivary Gland Cancer AJCC V7Stage I Nasopharyngeal Carcinoma AJCC V7Stage I Oral Cavity Cancer AJCC V6 and V7Stage I Oropharyngeal Carcinoma AJCC V6 and V7المرحلة الثانية من سرطان القولون والمستقيم AJCC v7Stage II Hypopharyngeal Carcinoma AJCC V6 and V7Stage II Major Salivary Gland Cancer AJCC V7Stage II Nasopharyngeal Carcinoma AJCC V7Stage II Oral Cavity Cancer AJCC V6 and V7Stage II Oropharyngeal Carcinoma AJCC V6 and V7Stage IIA Colorectal Cancer AJCC V7Stage IIB Colorectal Cancer AJCC V7Stage IIC Colorectal Cancer AJCC V7سرطان القولون والمستقيم المرحلة الثالثة AJCC الإصدار 7Stage III Hypopharyngeal Carcinoma AJCC V7Stage III Laryngeal Cancer AJCC V6 and V7Stage III Major Salivary Gland Cancer AJCC V7المرحلة III من سرطان البلعوم الأنفي AJCC v7Stage III Oral Cavity Cancer AJCC V6 and V7Stage III Oropharyngeal Carcinoma AJCC V7المرحلة الثالثة أ سرطان القولون والمستقيم AJCC v7المرحلة الثالثة ب سرطان القولون والمستقيم AJCC v7المرحلة IIIC سرطان القولون والمستقيم AJCC v7المرحلة IV سرطان القولون والمستقيم AJCC v7المرحلة IVA من سرطان القولون والمستقيم AJCC v7Stage IVA Hypopharyngeal Carcinoma AJCC V7Stage IVA Laryngeal Cancer AJCC V7المرحلة IVA من سرطان الغدد اللعابية الكبرى AJCC v7المرحلة IVA من سرطان البلعوم الأنفي AJCC v7المرحلة IVA من سرطان تجويف الفم AJCC v6 و v7Stage IVA Oropharyngeal Carcinoma AJCC V7المرحلة IVB من سرطان القولون والمستقيم AJCC v7Stage IVB Hypopharyngeal Carcinoma AJCC V7Stage IVB Laryngeal Cancer AJCC V7المرحلة IVB من سرطان الغدد اللعابية الكبرى AJCC v7سرطان البلعوم الأنفي المرحلة الرابعة ب AJCC v7المرحلة IVB من سرطان تجويف الفم AJCC v6 و v7Stage IVB Oropharyngeal Carcinoma AJCC V7Metastatic or Locally Unresectable Solid Tumorمعرّفات دراسة أخرى
- 2010-0955
- NCI-2014-02468 (معرف السجل) (CTRP (Clinical Trial Reporting Program))
- 2010-0955 (معرف آخر) (M D Anderson Cancer Center)
- R01CA243554 (منحة/عقد NIH الأمريكي)
- RC2CA148263 (منحة/عقد NIH الأمريكي)
- R01CA177996 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2011-05-25
آخر تحديث مُنشور
2025-08-03
تاريخ الاكتمال (المقدر)
2027-06-30
عدد المشاركين المخطط لهم
٥٩٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الغرض الأساسي
بحوث خدمات صحية
طريقة توزيع المشاركين
غير عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةArm 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. | Health Telemonitoring Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone إدارة الاستبيان Ancillary studies |
تجريبيةArm 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. | Health Telemonitoring Use accelerometers, blood pressure monitor, weight scale, and smart phone إدارة الاستبيان Ancillary studies |
تجريبيةArm 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. | Health Telemonitoring Use smart phone إدارة الاستبيان Ancillary studies |
تجريبيةArm 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. | Health Telemonitoring Use CO monitor and smart phone إدارة الاستبيان Ancillary studies |
تجريبيةPCS (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. | تدخل التمارين Participate in walking and/or strengthening program Health Telemonitoring Use Fitbit, weight scale and iPhone- or web-based app for self-reported data تقييم جودة الحياة Ancillary studies إدارة الاستبيان Ancillary studies |
تجريبيةTAPS (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. | Health Telemonitoring Use Fitbit and Actigraph |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Study completion (defined as completing the final assessment) | Up to 7 months after baseline | |
Physical Activity (PA) Assessment | 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) | Up to 7 days |
ECOG Performance Status | 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. | Up to 2 weeks |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Correlation between PA data from the Actigraph and Fitbit | Association between PA measured using a Fitbit and PA measured using Actigraph | Up to 7 days |
Correlation between patients' ECOG performance status scores and PA data | Association between performance status (PS) assesses by the patient's medical oncologist, and PA data | Up to 7 days |
Correlation between PA data and Overall Survivor (OS) | Association between Physical Activity (PA) data and the Overall Survivor (OS) rate | Up to 7 days |
Accrual of Diverse Sample of Cancer-Patients | Up to 2 weeks | |
Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants. | 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 | |
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 | |
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 | |
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 | |
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 |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- 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)
- 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)
مركز إم دي أندرسون للسرطان 1128 تجارب سريرية نشطة للاستكشافالمعهد الوطني للسرطان3028 تجارب سريرية نشطة للاستكشافجهة اتصال مركزية للدراسة
جهة اتصال: Susan Peterson, 713-792-8267, [email protected]
1 مواقع الدراسة في 1 بلدان
Texas
M D Anderson Cancer Center, Houston, Texas, 77030, United States
Susan K. Peterson, جهة اتصال, 713-792-8267
Susan K. Peterson, المحقق الرئيسي
قيد التجنيد