Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Purpose
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.
Condition
- Cigarette Smoking-Related Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group I (SGR program, text messages) |
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. |
|
|
Active Comparator Group II (booklet) |
Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. |
|
Recruiting Locations
Kingman, Arizona 86401
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
St. Helena, California 94574
Site Public Contact
707-967-3698
Braselton, Georgia 30517
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Site Public Contact
770-219-9010
Savannah, Georgia 31404
Savannah, Georgia 31404
Coeur d'Alene, Idaho 83814
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Aurora, Illinois 60504
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Canton, Illinois 61520
Carthage, Illinois 62321
Centralia, Illinois 62801
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
Dixon, Illinois 61021
Site Public Contact
815-285-7800
Effingham, Illinois 62401
Effingham, Illinois 62401
Eureka, Illinois 61530
Galesburg, Illinois 61401
Kewanee, Illinois 61443
Macomb, Illinois 61455
Mattoon, Illinois 61938
Mount Vernon, Illinois 62864
Normal, Illinois 61761
Normal, Illinois 61761
O'Fallon, Illinois 62269
Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peru, Illinois 61354
Princeton, Illinois 61356
Rockford, Illinois 61108
Site Public Contact
815-227-2633
Springfield, Illinois 62702
Site Public Contact
217-545-7929
Springfield, Illinois 62702
Site Public Contact
800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Urbana, Illinois 61801
Washington, Illinois 61571
Yorkville, Illinois 60560
Ankeny, Iowa 50023
Site Public Contact
515-241-3305
Bettendorf, Iowa 52722
Carroll, Iowa 51401
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52403
Site Public Contact
319-363-2690
Clive, Iowa 50325
Site Public Contact
515-241-3305
Des Moines, Iowa 50309
Site Public Contact
515-241-6727
Des Moines, Iowa 50309
Site Public Contact
515-241-3305
Des Moines, Iowa 50314
Site Public Contact
515-282-2200
Des Moines, Iowa 50314
Site Public Contact
515-241-3305
Des Moines, Iowa 50314
Site Public Contact
515-241-3305
Fort Dodge, Iowa 50501
Iowa City, Iowa 52242
Site Public Contact
800-237-1225
Waukee, Iowa 50263
Site Public Contact
515-241-3305
West Des Moines, Iowa 50266
Site Public Contact
515-875-9815
Hays, Kansas 67601
Site Public Contact
785-623-5774
Lawrence, Kansas 66044
Olathe, Kansas 66061
Salina, Kansas 67401
Topeka, Kansas 66606
Site Public Contact
785-270-4939
Topeka, Kansas 66606
Site Public Contact
785-295-8000
Bardstown, Kentucky 40004
Lexington, Kentucky 40504
Lexington, Kentucky 40509
London, Kentucky 40741
Lafayette, Louisiana 70503
Site Public Contact
337-289-8400
New Orleans, Louisiana 70112
New Orleans, Louisiana 70121
Escanaba, Michigan 49829
Grand Rapids, Michigan 49503
Marquette, Michigan 49855
Reed City, Michigan 49677
Saint Joseph, Michigan 49085
Traverse City, Michigan 49684
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Ely, Minnesota 55731
Site Public Contact
218-365-7900
Hibbing, Minnesota 55746
Site Public Contact
218-786-3308
International Falls, Minnesota 56649
Site Public Contact
218-283-9431
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Ballwin, Missouri 63011
Site Public Contact
888-446-3729
Cape Girardeau, Missouri 63703
Farmington, Missouri 63640
Site Public Contact
314-996-5569
Kansas City, Missouri 64108
Site Public Contact
816-404-4375
Osage Beach, Missouri 65065
Rolla, Missouri 65401
Site Public Contact
573-458-6379
Rolla, Missouri 65401
Saint Joseph, Missouri 64506
Sainte Genevieve, Missouri 63670
Site Public Contact
314-996-5569
Springfield, Missouri 65804
Site Public Contact
417-269-4520
Springfield, Missouri 65807
Site Public Contact
417-269-4520
St Louis, Missouri 63104
Site Public Contact
314-977-4440
St Louis, Missouri 63128
St Louis, Missouri 63131
Site Public Contact
314-996-5569
St Louis, Missouri 63141
Site Public Contact
314-251-7066
Sullivan, Missouri 63080
Site Public Contact
314-996-5569
Sunset Hills, Missouri 63127
Site Public Contact
314-996-5569
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59804
Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Carson City, Nevada 89703
Reno, Nevada 89502
Lebanon, New Hampshire 03756
Vineland, New Jersey 08360
Site Public Contact
856-641-7933
Albuquerque, New Mexico 87106
Las Cruces, New Mexico 88011
Cooperstown, New York 13326
Clemmons, North Carolina 27012
Clinton, North Carolina 28328
Durham, North Carolina 27705
Durham, North Carolina 27710
Site Public Contact
888-275-3853
Goldsboro, North Carolina 27534
Greensboro, North Carolina 27403
Hendersonville, North Carolina 28791
Jacksonville, North Carolina 28546
Kernersville, North Carolina 27284
Mount Airy, North Carolina 27030
Thomasville, North Carolina 27360
Winston-Salem, North Carolina 27103
Fargo, North Dakota 58103
Belpre, Ohio 45714
Chillicothe, Ohio 45601
Mount Vernon, Ohio 43050
Perrysburg, Ohio 43551
Toledo, Ohio 43623
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Danville, Pennsylvania 17822
Hazleton, Pennsylvania 18201
Lewisburg, Pennsylvania 17837
Pottsville, Pennsylvania 17901
Scranton, Pennsylvania 18510
Wilkes-Barre, Pennsylvania 18711
Johnson City, Tennessee 37604
Kingsport, Tennessee 37660
Abilene, Texas 79601
Site Public Contact
325-670-6340
Edinburg, Texas 78539
Saint Johnsbury, Vermont 05819
Bristol, Virginia 24201
Chesapeake, Virginia 23320
Martinsville, Virginia 24112
Richmond, Virginia 23249
Richmond, Virginia 23298
South Hill, Virginia 23970
Bridgeport, West Virginia 26330
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Princeton, West Virginia 24740
Site Public Contact
304-487-7515
Ashland, Wisconsin 54806
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
La Crosse, Wisconsin 54601
New Richmond, Wisconsin 54017
Oconto Falls, Wisconsin 54154
Sturgeon Bay, Wisconsin 54235-1495
Superior, Wisconsin 54880
Site Public Contact
701-364-6272
Rock Springs, Wyoming 82901
More Details
- NCT ID
- NCT05008848
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
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.