Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
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.
Arms & interventions
- BehavioralSmoking Cessation Intervention
Participate in schedule gradual reduction program
- OtherHealth Promotion and Education
Receive cessation support messages
- OtherInformational Intervention
Receive NCI's Clearing the Air booklet
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Biochemically validated tobacco cessation
Response will be defined as (1) urine cotinine levels \< 50 ng/ml or (2) urine cotinine levels \>=50 ng/ml and an urine anabasine level \< 2 ng/ml if a patient self-reports vaping use or the use of nicotine replacement therapy (NRT). Patients who do not return at 6 months post-quit date for the cotinine assessment (and anabasine, if applicable) will be deemed non-responders. The analysis population is defined as all randomized and eligible patients. The primary evaluation of the primary outcome will be the covariate-adjusted intervention effect (adjusted odds ratio) obtained from a multiple logistic regression model adjusted for the three stratification factors baseline daily cigarette consumption, age, and sex as well as the potential confounding variables cancer diagnosis, cancer type, receipt of chemotherapy, receipt of radiation therapy, and active treatment.
Time frame: Up to 6 months post-quit date
Secondary
Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date
Time frame: Up to 6-months post-quit date
Eligibility criteria
Study locations (222)
Kingman Regional Medical Center
Kingman, Arizona, 86401
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Saint Helena Hospital
St. Helena, California, 94574
Banner North Colorado Medical Center
Greeley, Colorado, 80631
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
The Longstreet Clinic - Gainesville
Gainesville, Georgia, 30501
Low Country Cancer Care
Savannah, Georgia, 31404
Memorial Health University Medical Center
Savannah, Georgia, 31404
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Rush-Copley Medical Center
Aurora, Illinois, 60504
Carle BroMenn Outpatient Center
Bloomington, Illinois, 61704
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Illinois CancerCare-Canton
Canton, Illinois, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Centralia Oncology Clinic
Centralia, Illinois, 62801
Saint Mary's Hospital
Centralia, Illinois, 62801
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Carle BroMenn Medical Center
Normal, Illinois, 61761
Carle Cancer Institute Normal
Normal, Illinois, 61761
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
OSF Saint Anthony Medical Center
Rockford, Illinois, 61108
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Carle Cancer Center
Urbana, Illinois, 61801
The Carle Foundation Hospital
Urbana, Illinois, 61801
Illinois CancerCare - Washington
Washington, Illinois, 61571
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
The Iowa Clinic PC
West Des Moines, Iowa, 50266
HaysMed
Hays, Kansas, 67601
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Salina Regional Health Center
Salina, Kansas, 67401
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
Saint Joseph Hospital
Lexington, Kentucky, 40504
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Saint Joseph London
London, Kentucky, 40741
Cancer Center of Acadiana
Lafayette, Louisiana, 70503
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Schoolcraft Memorial Hospital
Manistique, Michigan, 49854
UP Health System Marquette
Marquette, Michigan, 49855
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Munson Medical Center
Traverse City, Michigan, 49684
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Mercy Hospital
Coon Rapids, Minnesota, 55433
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Fairview Southdale Hospital
Edina, Minnesota, 55435
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Unity Hospital
Fridley, Minnesota, 55432
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology - Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Monticello Cancer Center
Monticello, Minnesota, 55362
New Ulm Medical Center
New Ulm, Minnesota, 56073
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Lakeview Hospital
Stillwater, Minnesota, 55082
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Ridgeview Medical Center
Waconia, Minnesota, 55387
Rice Memorial Hospital
Willmar, Minnesota, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Parkland Health Center - Farmington
Farmington, Missouri, 63640
University Health Truman Medical Center
Kansas City, Missouri, 64108
Lake Regional Hospital
Osage Beach, Missouri, 65065
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Community Hospital of Anaconda
Anaconda, Montana, 59711
Billings Clinic Cancer Center
Billings, Montana, 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Logan Health Medical Center
Kalispell, Montana, 59901
Community Medical Center
Missoula, Montana, 59804
CHI Health Saint Francis
Grand Island, Nebraska, 68803
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Renown Regional Medical Center
Reno, Nevada, 89502
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Inspira Medical Center Vineland
Vineland, New Jersey, 08360
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
Novant Health Colon and Rectal Clinic
Clemmons, North Carolina, 27012
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Durham VA Medical Center
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Adena Regional Medical Center
Chillicothe, Ohio, 45601
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Knox Community Hospital
Mount Vernon, Ohio, 43050
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Community Medical Center
Scranton, Pennsylvania, 18510
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, 37604
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Hendrick Medical Center
Abilene, Texas, 79601
STCC at DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Doctor's Hospital of Laredo
Laredo, Texas, 78041
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
Peninsula Cancer Institute-Gloucester
Gloucester, Virginia, 23061
Sovah Health Martinsville
Martinsville, Virginia, 24112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, 23249
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Sentara Princess Anne Hospital
Virginia Beach, Virginia, 23456
United Hospital Center
Bridgeport, West Virginia, 26330
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Princeton Community Hospital
Princeton, West Virginia, 24740
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
SSM Health Dean Medical Group - Baraboo
Baraboo, Wisconsin, 53913
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
SSM Health Dean Medical Group - Janesville
Janesville, Wisconsin, 53546
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
SSM Health Dean Medical Group - South Madison Campus
Madison, Wisconsin, 53715
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Memorial Hospital of Sweetwater County
Rock Springs, Wyoming, 82901