Study Stopped
Slow accrual
Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
2 other identifiers
interventional
23
1 country
374
Brief Summary
This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline \[tobacco cessation service available through a toll-free telephone number\] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2017
Longer than P75 for phase_3
374 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedResults Posted
Study results publicly available
June 24, 2022
CompletedJuly 27, 2022
June 1, 2022
3.7 years
August 1, 2016
May 31, 2022
June 30, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Mortality
Number of patients that died within 30 days of surgery
Up to 30 days post-surgery
Re-hospitalization
Number of patients re-hospitalized within 30 days of surgery
Up to 30 days post-surgery
Number of Paticipants With Incidence of Pulmonary Complications
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Up to 24 weeks post-surgery
Number of Participants With Incidence of Intensive Care Unit Readmission
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Up to 24 weeks post-surgery
Number of Participants With Incidence of Unspecified Wound Infection
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Up to 24 weeks post-surgery
Number of Participants With Incidence of Anastomotic Failure
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Up to 24 weeks post-surgery
Secondary Outcomes (9)
Change in QOL as Measured by the LASA-12, PHQ-9, SEQ-12
Baseline up to 24 weeks after surgery
Change in QOL as Measured by Was It Worth It Assessments
At 12 weeks after surgery
Change in QOL as Measured by Was It Worth It Assessments
At 24 weeks after surgery
Length of Hospital Stay
The time from surgery until the patient is released from the hospital
Length of High Dependency Unit Stay
The time from surgery until the patient is released from the hospital
- +4 more secondary outcomes
Study Arms (2)
Intervention group (varenicline and behavioral intervention)
EXPERIMENTALPatients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
Control group (placebo and behavioral intervention)
PLACEBO COMPARATORPatients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
Interventions
Complete counseling session
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Alliance for Clinical Trials in Oncologylead
- National Cancer Institute (NCI)collaborator
- Pfizercollaborator
Study Sites (374)
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Saint Helena Hospital
St. Helena, California, 94574, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204, United States
National Jewish Health-Main Campus
Denver, Colorado, 80206, United States
The Women's Imaging Center
Denver, Colorado, 80209, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western Surgical Care
Denver, Colorado, 80220, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Good Samaritan Medical Center
Lafayette, Colorado, 80026, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado, 80260, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut, 06516, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Indian River Medical Center
Vero Beach, Florida, 32960, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Summit Cancer Care-Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, 83686, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, 62226, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, 46545, United States
Franciscan Health Mooresville
Mooresville, Indiana, 46158, United States
Chancellor Center for Oncology
Newburgh, Indiana, 47630, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Baptist Health Corbin
Corbin, Kentucky, 40701, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville, Kentucky, 42431, United States
Baptist Health Paducah
Paducah, Kentucky, 42003, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816, United States
Ochsner High Grove
Baton Rouge, Louisiana, 70836, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
Mercy Medical Center
Springfield, Massachusetts, 01104, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, 48114, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114, United States
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, 48188, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, 48118, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, 48124, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, 48054, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Hope Cancer Clinic
Livonia, Michigan, 48154, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044, United States
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
UP Health System Hematology Oncology Marquette
Marquette, Michigan, 49855, United States
UP Health System Marquette
Marquette, Michigan, 49855, United States
21st Century Oncology-Pontiac
Pontiac, Michigan, 48341, United States
Hope Cancer Center
Pontiac, Michigan, 48341, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Huron Medical Center PC
Port Huron, Michigan, 48060, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, 48309, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764, United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
Michigan Breast Specialists-Warren
Warren, Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, 48197, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
21st Century Oncology-Henderson
Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
OptumCare Cancer Care at Oakey
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
21st Century Oncology
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121, United States
21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada, 89128, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
21st Century Oncology-Fort Apache
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Ocean Medical Center
Brick, New Jersey, 08724, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690, United States
Bayshore Community Hospital
Holmdel, New Jersey, 07733, United States
Southern Ocean County Medical Center
Manahawkin, New Jersey, 08050, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
University of Rochester
Rochester, New York, 14642, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Alliance Cancer Center
Alliance, Ohio, 44601, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
First Dayton Cancer Care
Kettering, Ohio, 45420, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Dayton Physicians LLC-Upper Valley
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg
Spartanburg, South Carolina, 29307, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Sentara Martha Jefferson Hospital
Charlottesville, Virginia, 22901, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, 98110, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Virginia Mason Federal Way Medical Center
Federal Way, Washington, 98002, United States
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor, Washington, 98332, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335, United States
Northwest Cancer Clinic
Kennewick, Washington, 99336, United States
Virginia Mason Lynnwood Medical Center
Lynnwood, Washington, 98036, United States
Jefferson Healthcare
Port Townsend, Washington, 98368, United States
Peninsula Cancer Center
Poulsbo, Washington, 98370, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
Tacoma/Valley Radiation Oncology Centers-Puyallup
Puyallup, Washington, 98372, United States
Valley Medical Center
Renton, Washington, 98055, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, 99204, United States
Rockwood North Cancer Treatment Center
Spokane, Washington, 99218, United States
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, 99216, United States
Tacoma/Valley Radiation Oncology Centers-Jackson Hall
Tacoma, Washington, 97405, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma, Washington, 98405, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ivana T. Croghan
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Ivana Croghan, PhD
Mayo
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 5, 2016
Study Start
September 29, 2017
Primary Completion
May 28, 2021
Study Completion
April 15, 2022
Last Updated
July 27, 2022
Results First Posted
June 24, 2022
Record last verified: 2022-06