LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
Sponsored by University of Rochester
About this study
This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
PRIMARY OBJECTIVE: I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. SECONDARY OBJECTIVES: I. To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente. III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cache…
Where this study is enrolling (196)
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Mercy Hospital Fort Smith
Fort Smith, Arkansas
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Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware
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Beebe South Coastal Health Campus
Millville, Delaware
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Christiana Care Health System-Christiana Hospital
Newark, Delaware
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Beebe Health Campus
Rehoboth Beach, Delaware
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Helen F Graham Cancer Center
Newark, Delaware
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Medical Oncology Hematology Consultants PA
Newark, Delaware
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia
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Memorial Health University Medical Center
Savannah, Georgia
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Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia
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Northside Hospital
Atlanta, Georgia
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Braselton, Georgia
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John B Amos Cancer Center
Columbus, Georgia
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Northside Hospital - Duluth
Duluth, Georgia
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The Longstreet Clinic - Gainesville
Gainesville, Georgia
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Northside Hospital - Gwinnett
Lawrenceville, Georgia
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Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia
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Tift Regional Medical Center
Tifton, Georgia
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South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia
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Straub Clinic and Hospital
Honolulu, Hawaii
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Queen's Cancer Center - Kuakini
Honolulu, Hawaii
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii
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Hawaii Cancer Care - Westridge
‘Aiea, Hawaii
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Pali Momi Medical Center
‘Aiea, Hawaii
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Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii
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Queen's Medical Center
Honolulu, Hawaii
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‘Ewa Beach, Hawaii
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Queen's Cancer Cenrer - POB I
Honolulu, Hawaii
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Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii
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Springfield Memorial Hospital
Springfield, Illinois
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OSF Saint Anthony's Health Center
Alton, Illinois
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Advocate Good Shepherd Hospital
Barrington, Illinois
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Illinois CancerCare-Bloomington
Bloomington, Illinois
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Canton, Illinois
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Carbondale, Illinois
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SIH Cancer Institute
Carterville, Illinois
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Carthage, Illinois
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Centralia, Illinois
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Chicago, Illinois
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Crystal Lake, Illinois
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Danville, Illinois
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Decatur, Illinois
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Decatur, Illinois
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Dixon, Illinois
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Downers Grove, Illinois
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Effingham, Illinois
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Elgin, Illinois
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Eureka, Illinois
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Galesburg, Illinois
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Hazel Crest, Illinois
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Kewanee, Illinois
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Libertyville, Illinois
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Libertyville, Illinois
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Macomb, Illinois
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Normal, Illinois
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Normal, Illinois
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O'Fallon, Illinois
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O'Fallon, Illinois
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Advocate Christ Medical Center
Oak Lawn, Illinois
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Oak Lawn, Illinois
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Ottawa, Illinois
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Park Ridge, Illinois
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Pekin, Illinois
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Peoria, Illinois
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Peoria, Illinois
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Peru, Illinois
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Valley Radiation Oncology
Peru, Illinois
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Princeton, Illinois
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Southern Illinois University School of Medicine
Springfield, Illinois
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Springfield, Illinois
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Urbana, Illinois
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Washington, Illinois
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New Orleans, Louisiana
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Elkton, Maryland
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Grand Rapids, Michigan
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Grand Rapids, Michigan
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Iron Mountain, Michigan
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Kalamazoo, Michigan
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Kalamazoo, Michigan
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Wyoming, Minnesota
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Burnsville, Minnesota
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Coon Rapids, Minnesota
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Maple Grove, Minnesota
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Maplewood, Minnesota
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Maplewood, Minnesota
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Minneapolis, Minnesota
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Monticello, Minnesota
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Saint Louis Park, Minnesota
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Saint Paul, Minnesota
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Shakopee, Minnesota
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Stillwater, Minnesota
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Waconia, Minnesota
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Woodbury, Minnesota
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North Memorial Medical Health Center
Robbinsdale, Minnesota
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Missouri Baptist Medical Center
St Louis, Missouri
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Missouri Baptist Sullivan Hospital
Sullivan, Missouri
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Sunset Hills, Missouri
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Osage Beach, Missouri
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Parkland Health Center - Farmington
Farmington, Missouri
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri
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Mercy Hospital Springfield
Springfield, Missouri
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St Louis, Missouri
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Urology Specialists of Nevada - Green Valley
Henderson, Nevada
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Las Vegas, Nevada
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Las Vegas, Nevada
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Las Vegas, Nevada
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Reno, Nevada
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Carson City, Nevada
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Henderson, Nevada
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OptumCare Cancer Care at Seven Hills
Henderson, Nevada
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Henderson, Nevada
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Las Vegas, Nevada
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Las Vegas, Nevada
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Pluta Cancer Center
Rochester, New York
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University of Rochester
Rochester, New York
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Wilmot Cancer Institute at Webster
Webster, New York
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Lenox Hill Hospital
New York, New York
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Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York
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Highland Hospital
Rochester, New York
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Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York
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Northwell Health/Center for Advanced Medicine
Lake Success, New York
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Manhattan Eye Ear and Throat Hospital
New York, New York
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Strecker Cancer Center-Belpre
Belpre, Ohio
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Marietta Memorial Hospital
Marietta, Ohio
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Providence Portland Medical Center
Portland, Oregon
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Providence Newberg Medical Center
Newberg, Oregon
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Portland, Oregon
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Oregon City, Oregon
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Geisinger Medical Center
Danville, Pennsylvania
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Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania
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Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania
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SMC Center for Hematology Oncology Union
Union, South Carolina
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Gibbs Cancer Center-Gaffney
Gaffney, South Carolina
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AnMed Health Cancer Center
Anderson, South Carolina
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Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina
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Prisma Health Cancer Institute - Faris
Greenville, South Carolina
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Greenville, South Carolina
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Greer, South Carolina
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Hilton Head Island, South Carolina
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Greenville, South Carolina
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Spartanburg, South Carolina
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South Hill, Virginia
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Winchester, Virginia
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PeaceHealth Saint John Medical Center
Longview, Washington
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PeaceHealth Southwest Medical Center
Vancouver, Washington
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PeaceHealth Saint Joseph Medical Center
Bellingham, Washington
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Renton, Washington
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Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin
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Milwaukee, Wisconsin
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Milwaukee, Wisconsin
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Minocqua, Wisconsin
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Cancer Center of Western Wisconsin
New Richmond, Wisconsin
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Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin
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Racine, Wisconsin
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Racine, Wisconsin
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Rice Lake, Wisconsin
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Sheboygan, Wisconsin
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Stevens Point, Wisconsin
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Summit, Wisconsin
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Two Rivers, Wisconsin
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Wauwatosa, Wisconsin
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Wauwatosa, Wisconsin
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West Allis, Wisconsin
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Sturgeon Bay, Wisconsin
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Appleton, Wisconsin
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Appleton, Wisconsin
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Brookfield, Wisconsin
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Burlington, Wisconsin
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Chilton, Wisconsin
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Cudahy, Wisconsin
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Eau Claire, Wisconsin
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Franklin, Wisconsin
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Germantown, Wisconsin
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Grafton, Wisconsin
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Green Bay, Wisconsin
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Green Bay, Wisconsin
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Green Bay, Wisconsin
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Greenfield, Wisconsin
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Kenosha, Wisconsin
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Marinette, Wisconsin
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Marshfield, Wisconsin
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Mequon, Wisconsin
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Milwaukee, Wisconsin
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Oshkosh, Wisconsin
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Weston, Wisconsin
Who can participate
Inclusion criteria
- ✓Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
- ✓Note: Patients do not need to have cachexia to be eligible
- ✓Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
- ✓NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended \> 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy \[RT\]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible
- ✓Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- ✓Be able to understand, speak and read English
- ✓Be 18 years of age or older
Exclusion criteria
- ✕Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee
- ✕Have any planned major surgeries within the next 3 months
- ✕Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
- ✕Be pregnant
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.