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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"

Primary Purpose

Malignant Head and Neck Neoplasm, Malignant Neoplasm, Metastatic Malignant Neoplasm in the Neck

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Health Telemonitoring
Health Telemonitoring
Health Telemonitoring
Health Telemonitoring
Health Telemonitoring
Quality-of-Life Assessment
Questionnaire Administration
Health Telemonitoring
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malignant Head and Neck Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm I (colorectal cancer patients)

Arm II (head and neck cancer patients)

Arm III (head and neck cancer patients)

Arm IV (cancer survivors that are current/former smokers)

PCS (pancreatic surgery patients)

TAPS (Technological Approach to Performance Status)

Arm Description

(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.

(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.

(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.

(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.

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.

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.

Outcomes

Primary Outcome Measures

Study completion (defined as completing the final assessment)
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)
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.

Secondary Outcome Measures

Correlation between PA data from the Actigraph and Fitbit
Association between PA measured using a Fitbit and PA measured using Actigraph
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
Correlation between PA data and Overall Survivor (OS)
Association between Physical Activity (PA) data and the Overall Survivor (OS) rate
Accrual of Diverse Sample of Cancer-Patients
Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).
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.
Successful upload of data from the home-based health monitor devices to the Cyberinfrastructure for Comparative effectiveness Research (CYCORE) for future analysis.
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).

Full Information

First Posted
June 1, 2011
Last Updated
August 9, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01365169
Brief Title
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"
Official Title
"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2011 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Head and Neck Neoplasm, Malignant Neoplasm, Metastatic Malignant Neoplasm in the Neck, Metastatic Malignant Neoplasm in the Uterine Cervix, Pancreatic Adenocarcinoma, Pancreatic Neuroendocrine Carcinoma, Recurrent Colorectal Carcinoma, Stage I Colorectal Cancer AJCC v6 and v7, 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, Stage II Colorectal Cancer 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, Stage III Colorectal Cancer AJCC v7, Stage III Hypopharyngeal Carcinoma AJCC v7, Stage III Laryngeal Cancer AJCC v6 and v7, Stage III Major Salivary Gland Cancer AJCC v7, Stage III Nasopharyngeal Carcinoma AJCC v7, Stage III Oral Cavity Cancer AJCC v6 and v7, Stage III Oropharyngeal Carcinoma AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIB Colorectal Cancer AJCC v7, Stage IIIC Colorectal Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVA Hypopharyngeal Carcinoma AJCC v7, Stage IVA Laryngeal Cancer AJCC v7, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IVA Nasopharyngeal Carcinoma AJCC v7, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage IVA Oropharyngeal Carcinoma AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Stage IVB Hypopharyngeal Carcinoma AJCC v7, Stage IVB Laryngeal Cancer AJCC v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage IVB Nasopharyngeal Carcinoma AJCC v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IVB Oropharyngeal Carcinoma AJCC v7, Metastatic or Locally Unresectable Solid Tumor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (colorectal cancer patients)
Arm Type
Experimental
Arm Description
(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.
Arm Title
Arm II (head and neck cancer patients)
Arm Type
Experimental
Arm Description
(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 Title
Arm III (head and neck cancer patients)
Arm Type
Experimental
Arm Description
(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 Title
Arm IV (cancer survivors that are current/former smokers)
Arm Type
Experimental
Arm Description
(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.
Arm Title
PCS (pancreatic surgery patients)
Arm Type
Experimental
Arm Description
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.
Arm Title
TAPS (Technological Approach to Performance Status)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Participate in walking and/or strengthening program
Intervention Type
Other
Intervention Name(s)
Health Telemonitoring
Intervention Description
Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
Intervention Type
Other
Intervention Name(s)
Health Telemonitoring
Intervention Description
Use accelerometers, blood pressure monitor, weight scale, and smart phone
Intervention Type
Other
Intervention Name(s)
Health Telemonitoring
Intervention Description
Use smart phone
Intervention Type
Other
Intervention Name(s)
Health Telemonitoring
Intervention Description
Use CO monitor and smart phone
Intervention Type
Other
Intervention Name(s)
Health Telemonitoring
Intervention Description
Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Health Telemonitoring
Intervention Description
Use Fitbit and Actigraph
Primary Outcome Measure Information:
Title
Study completion (defined as completing the final assessment)
Time Frame
Up to 7 months after baseline
Title
Physical Activity (PA) Assessment
Description
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)
Time Frame
Up to 7 days
Title
ECOG Performance Status
Description
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.
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Correlation between PA data from the Actigraph and Fitbit
Description
Association between PA measured using a Fitbit and PA measured using Actigraph
Time Frame
Up to 7 days
Title
Correlation between patients' ECOG performance status scores and PA data
Description
Association between performance status (PS) assesses by the patient's medical oncologist, and PA data
Time Frame
Up to 7 days
Title
Correlation between PA data and Overall Survivor (OS)
Description
Association between Physical Activity (PA) data and the Overall Survivor (OS) rate
Time Frame
Up to 7 days
Title
Accrual of Diverse Sample of Cancer-Patients
Time Frame
Up to 2 weeks
Title
Retention of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Time Frame
Up to 2 weeks
Title
Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.
Time Frame
Up to 2 weeks
Title
Participants ability to activate, set-up, and use the home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales).
Time Frame
Up to 2 weeks
Title
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.
Time Frame
Up to 2 weeks
Title
Successful upload of data from the home-based health monitor devices to the Cyberinfrastructure for Comparative effectiveness Research (CYCORE) for future analysis.
Time Frame
Up to 2 weeks
Title
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).
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Peterson
Phone
713-792-8267
Email
speterso@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Peterson
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan K. Peterson
Phone
713-792-8267
First Name & Middle Initial & Last Name & Degree
Susan K. Peterson

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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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"

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