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NCT05008848PHASE3Recruiting

Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

Alliance for Clinical Trials in Oncology

Start Date

4/1/2022

Completion Date

8/1/2027

Summary

This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of an eight-week text-based scheduled gradual reduction (SGR) intervention (a personalized eight-week reduction schedule paired with National Cancer Institute's \[NCI's\] Smokefree.TXT) compared to a control intervention (NCI Clearing the Air Cessation Booklet) on biochemically-validated smoking cessation six-month post-quit date in rural cancer survivors. SECONDARY OBJECTIVE: I. Compare the efficacy of the eight-week text-based SGR intervention and a control intervention on Linear Analog Self-Assessment (LASA)-6 overall quality of life (QOL) at 30-days post-quit date and six-months post-quit date. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients participate in schedule gradual reduction program over 8 weeks to reduce the frequency of cigarette use. Patients also receive cessation support messages via text messages for 12 weeks. GROUP II: Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. After completion of study, patients are followed up at 6 months.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment * Not currently on hospice * Currently smokes \>= 5 cigarettes daily * Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code \[RUCC\] code of 4-9) * Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial * Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program * Patient has a cell phone or smart phone device with texting ability * In order to complete the mandatory patient-completed measures, participants must be able to speak and read English * Age \>= 18 years * Participant must be willing to provide a urine sample. Exclusion Criteria: * Psychiatric illness which would prevent the patient from giving informed consent * Patients with impaired decision-making capacity are not eligible for this study.

Interventions

BEHAVIORAL

Smoking Cessation Intervention

OTHER

Health Promotion and Education

OTHER

Informational Intervention

OTHER

Questionnaire Administration

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Conditions

Cigarette Smoking-Related Carcinoma

Locations

Kingman Regional Medical Center

Kingman, Arizona 86401

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas 72903

United States

Saint Helena Hospital

St. Helena, California 94574

United States

Banner North Colorado Medical Center

Greeley, Colorado 80631

United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado 80539

United States

Northeast Georgia Medical Center Braselton

Braselton, Georgia 30517

United States

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia 30501

United States

The Longstreet Clinic - Gainesville

Gainesville, Georgia 30501

United States

Low Country Cancer Care

Savannah, Georgia 31404

United States

Memorial Health University Medical Center

Savannah, Georgia 31404

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 Health - Coeur d'Alene

Coeur d'Alene, Idaho 83814

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho 83864

United States

OSF Saint Anthony's Health Center

Alton, Illinois 62002

United States

Rush-Copley Medical Center

Aurora, Illinois 60504

United States

Carle BroMenn Outpatient Center

Bloomington, Illinois 61704

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois 61704

United States

Illinois CancerCare-Canton

Canton, Illinois 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois 62321

United States

Centralia Oncology Clinic

Centralia, Illinois 62801

United States

Saint Mary's Hospital

Centralia, Illinois 62801

United States

Carle at The Riverfront

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

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

SSM Health Good Samaritan

Mount Vernon, Illinois 62864

United States

Carle BroMenn Medical Center

Normal, Illinois 61761

United States

Carle Cancer Institute Normal

Normal, Illinois 61761

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois 62269

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois 61615

United States

Illinois CancerCare-Peru

Peru, Illinois 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois 61356

United States

OSF Saint Anthony Medical Center

Rockford, Illinois 61108

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Springfield Clinic

Springfield, Illinois 62702

United States

Springfield Memorial Hospital

Springfield, Illinois 62781

United States

Carle Cancer Center

Urbana, Illinois 61801

United States

The Carle Foundation Hospital

Urbana, Illinois 61801

United States

Illinois CancerCare - Washington

Washington, Illinois 61571

United States

Rush-Copley Healthcare Center

Yorkville, Illinois 60560

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa 50023

United States

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa 52722

United States

Saint Anthony Regional Hospital

Carroll, Iowa 51401

United States

Saint Luke's Hospital

Cedar Rapids, Iowa 52402

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa 52403

United States

Mercy Cancer Center-West Lakes

Clive, Iowa 50325

United States

Iowa Methodist Medical Center

Des Moines, Iowa 50309

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa 50309

United States

Broadlawns Medical Center

Des Moines, Iowa 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa 50314

United States

UI Healthcare Mission Cancer and Blood - Fort Dodge

Fort Dodge, Iowa 50501

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa 52242

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa 50263

United States

The Iowa Clinic PC

West Des Moines, Iowa 50266

United States

HaysMed

Hays, Kansas 67601

United States

Lawrence Memorial Hospital

Lawrence, Kansas 66044

United States

The University of Kansas Cancer Center - Olathe

Olathe, Kansas 66061

United States

Salina Regional Health Center

Salina, Kansas 67401

United States

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas 66606

United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas 66606

United States

CommonSpirit Saint Joseph Hospital - Bardstown

Bardstown, Kentucky 40004

United States

CommonSpirit Saint Joseph Hospital - Lexington

Lexington, Kentucky 40504

United States

CommonSpirit Saint Joseph Medical Center - East Lexington

Lexington, Kentucky 40509

United States

CommonSpirit Saint Joseph Hospital London

London, Kentucky 40741

United States

Cancer Center of Acadiana

Lafayette, Louisiana 70503

United States

Louisiana State University Health Science Center

New Orleans, Louisiana 70112

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

OSF Saint Francis Hospital and Medical Group

Escanaba, Michigan 49829

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan 49503

United States

Schoolcraft Memorial Hospital

Manistique, Michigan 49854

United States

UP Health System Marquette

Marquette, Michigan 49855

United States

Corewell Health Reed City Hospital

Reed City, Michigan 49677

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan 49085

United States

Munson Medical Center

Traverse City, Michigan 49684

United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota 56401

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota 55337

United States

Minnesota Oncology Hematology PA-Chaska

Chaska, Minnesota 55318

United States

Mercy Hospital

Coon Rapids, Minnesota 55433

United States

Minnesota Oncology - Coon Rapids

Coon Rapids, Minnesota 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota 56636

United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota 56501

United States

Essentia Health Cancer Center

Duluth, Minnesota 55805

United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota 55805

United States

Fairview Southdale Hospital

Edina, Minnesota 55435

United States

Minnesota Oncology - Edina

Edina, Minnesota 55435

United States

Essentia Health - Ely Clinic

Ely, Minnesota 55731

United States

Unity Hospital

Fridley, Minnesota 55432

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota 55746

United States

Essentia Health - International Falls Clinic

International Falls, Minnesota 56649

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota 55369

United States

Minnesota Oncology - Maple Grove

Maple Grove, Minnesota 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota 55109

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota 55407

United States

Hennepin County Medical Center

Minneapolis, Minnesota 55415

United States

Monticello Cancer Center

Monticello, Minnesota 55362

United States

New Ulm Medical Center

New Ulm, Minnesota 56073

United States

Essentia Health - Park Rapids

Park Rapids, Minnesota 56470

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota 55422

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota 55416

United States

Regions Hospital

Saint Paul, Minnesota 55101

United States

United Hospital

Saint Paul, Minnesota 55102

United States

Essentia Health Sandstone

Sandstone, Minnesota 55072

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota 55379

United States

Lakeview Hospital

Stillwater, Minnesota 55082

United States

Essentia Health Virginia Clinic

Virginia, Minnesota 55792

United States

Ridgeview Medical Center

Waconia, Minnesota 55387

United States

Rice Memorial Hospital

Willmar, Minnesota 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota 55125

United States

Fairview Lakes Medical Center

Wyoming, Minnesota 55092

United States

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri 63011

United States

Saint Francis Medical Center

Cape Girardeau, Missouri 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri 63640

United States

University Health Truman Medical Center

Kansas City, Missouri 64108

United States

Lake Regional Hospital

Osage Beach, Missouri 65065

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri 65401

United States

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri 64506

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri 63670

United States

Mercy Hospital Springfield

Springfield, Missouri 65804

United States

CoxHealth South Hospital

Springfield, Missouri 65807

United States

SSM Health Saint Louis University Hospital

St Louis, Missouri 63104

United States

Mercy Hospital South

St Louis, Missouri 63128

United States

Missouri Baptist Medical Center

St Louis, Missouri 63131

United States

Mercy Hospital Saint Louis

St Louis, Missouri 63141

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri 63080

United States

BJC Outpatient Center at 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

Bozeman Health Deaconess Hospital

Bozeman, Montana 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana 59405

United States

Great Falls Clinic

Great Falls, Montana 59405

United States

Logan Health Medical Center

Kalispell, Montana 59901

United States

Community Medical Center

Missoula, Montana 59804

United States

CHI Health Saint Francis

Grand Island, Nebraska 68803

United States

CHI Health Good Samaritan

Kearney, Nebraska 68847

United States

Carson Tahoe Regional Medical Center

Carson City, Nevada 89703

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire 03756

United States

Inspira Medical Center Vineland

Vineland, New Jersey 08360

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87106

United States

Memorial Medical Center-Las Cruces

Las Cruces, New Mexico 88011

United States

Mary Imogene Bassett Hospital

Cooperstown, New York 13326

United States

Novant Health Colon and Rectal Clinic

Clemmons, North Carolina 27012

United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina 28328

United States

Durham VA Medical Center

Durham, North Carolina 27705

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina 27534

United States

Novant Health Breast Surgery - Greensboro

Greensboro, North Carolina 27403

United States

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina 28791

United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina 28546

United States

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina 27284

United States

Novant Health Cancer Institute - Mount Airy

Mount Airy, North Carolina 27030

United States

Novant Health Cancer Institute - Thomasville

Thomasville, North Carolina 27360

United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina 27103

United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota 58103

United States

Strecker Cancer Center-Belpre

Belpre, Ohio 45714

United States

Adena Regional Medical Center

Chillicothe, Ohio 45601

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio 45219

United States

Knox Community Hospital

Mount Vernon, Ohio 43050

United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio 43551

United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio 43623

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio 45069

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma 73120

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon 97914

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania 18201

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania 17837

United States

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania 17901

United States

Community Medical Center

Scranton, Pennsylvania 18510

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania 18711

United States

Regional Cancer Center at Johnson City Medical Center

Johnson City, Tennessee 37604

United States

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee 37660

United States

Hendrick Medical Center

Abilene, Texas 79601

United States

STCC at DHR Health Institute for Research and Development

Edinburg, Texas 78539

United States

Doctor's Hospital of Laredo

Laredo, Texas 78041

United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont 05819

United States

Ballad Health Cancer Care - Bristol

Bristol, Virginia 24201

United States

Chesapeake Regional Medical Center

Chesapeake, Virginia 23320

United States

Peninsula Cancer Institute-Gloucester

Gloucester, Virginia 23061

United States

Sovah Health Martinsville

Martinsville, Virginia 24112

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia 23249

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

VCU Community Memorial Health Center

South Hill, Virginia 23970

United States

Sentara Princess Anne Hospital

Virginia Beach, Virginia 23456

United States

United Hospital Center

Bridgeport, West Virginia 26330

United States

West Virginia University Healthcare

Morgantown, West Virginia 26506

United States

Camden Clark Medical Center

Parkersburg, West Virginia 26101

United States

Princeton Community Hospital

Princeton, West Virginia 24740

United States

Aspirus Cancer Care-Antigo-Volm Cancer Center

Antigo, Wisconsin 54409

United States

Duluth Clinic Ashland

Ashland, Wisconsin 54806

United States

SSM Health Dean Medical Group - Baraboo

Baraboo, Wisconsin 53913

United States

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin 54701

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin 54303

United States

SSM Health Dean Medical Group - Janesville

Janesville, Wisconsin 53546

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin 54601

United States

SSM Health Dean Medical Group - South Madison Campus

Madison, Wisconsin 53715

United States

Aspirus Medford Hospital

Medford, Wisconsin 54451

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin 54017

United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin 54154

United States

Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

Rhinelander, Wisconsin 54501

United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin 54481

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin 54235-1495

United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin 54880

United States

Aspirus Cancer Care-Wausau

Wausau, Wisconsin 54401

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin 54494

United States

Memorial Hospital of Sweetwater County

Rock Springs, Wyoming 82901

United States