Cigarette Smoking-Related CarcinomaPhase 3NCT05008848
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
A Phase 3 study testing Smoking Cessation Intervention, Health Promotion and Education and Informational Intervention in people with Cigarette Smoking-Related Carcinoma, run by Alliance for Clinical Trials in Oncology at 223 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Smoking Cessation Intervention, Health Promotion and Education and Informational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 223 sitesUnited States
- Study dates
- 1 Apr 2022to 23 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a cancer diagnosis within the past 10 years
- Note: Patients with ductal carcinoma in situ (DCIS) are eligible and patients currently receiving curative treatment are eligible
- Not currently on hospice
- Currently smokes >= 5 cigarettes daily
- Note: Participants who smoke cigarettes and vape are eligible. Those who only vape are ineligible
- Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9) and/or a Rural-Urban Commuting area code of 4-10 and/or as defined by the Office of Management and Budget as a non-rural county large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with rural-urban commuting area (RUCA) codes 2-3; and outlying metro counties without a UA. The RUCC code and RUCA (4-10) codes can be checked at: https://www.ruralhealthinfo.org/am-i-rural. Those with RUCA codes of 2-3 can be checked at https://data.hrsa.gov/tools/rural-health for eligibility
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- 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 for smoking purposes only), or currently participating in any cessation program at the time of enrollment
- 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 or Spanish
- Age >= 18 years
- Participant must be willing to provide a urine sample.
- Patients with impaired decision-making capacity are not eligible for this study consent
Who cannot join
None listed.
Trial locations and contacts
223 sites in 1 country. Contact the study team or a site near you to ask about taking part.
223 sites in 1 country
United States223 sites, 207 recruiting
- Recruiting
Hendrick Medical Center
Abilene, Texas, 79601
Site Public Contact, 325-670-6340
Jose C. Velasco Di Domenico
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Moises Harari-Turquie
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Vamsi K. Vasireddy
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Active, not recruiting
SSM Health Dean Medical Group - Baraboo
Baraboo, Wisconsin, 53913
- Recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu
Stephanie Gilbertson-White
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Carle BroMenn Outpatient Center
Bloomington, Illinois, 61704
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
Site Public Contact, 770-219-8800, cancerpatient.navigator@nghs.com
Charles H. Nash
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Nour Daboul
- Recruiting
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Suspended
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-368-5514, Rachel.varner@unitypoint.org
Candace R. Correa
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Saint Mary's Hospital
Centralia, Illinois, 62801
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
Site Public Contact, CancerCare@ChesapeakeRegional.com
Antonio J. Ruiz
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Kerri McGovern
- Recruiting
Novant Health Colon and Rectal Clinic
Clemmons, North Carolina, 27012
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
Site Public Contact, 877-547-1750, CancerClinicalTrials@bassett.org
Timothy P. Korytko
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Rajiv Panikkar
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Site Public Contact, 218-249-7825, kdean@slhduluth.com
Homam Alkaied
- Recruiting
Durham VA Medical Center
Durham, North Carolina, 27705
Site Public Contact, 919-286-0411, VHADURcancertrials@va.gov
Daphne R. Friedman
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Linda M. Sutton
- Suspended
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
STCC at DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Site Public Contact, 956-362-2390, dhrresearch@dhr-rgv.com
Jose Cruz
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Site Public Contact, 218-365-7900
Bret E. Friday
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, 32610
Site Public Contact, 352-273-8675, trials@cancer.ufl.edu
Brittany K. Rogers
- Recruiting
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
Site Public Contact, 770-219-8800, cancerpatient.navigator@nghs.com
Charles H. Nash
- Recruiting
The Longstreet Clinic - Gainesville
Gainesville, Georgia, 30501
Site Public Contact, 770-219-9010
Charles H. Nash
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Peninsula Cancer Institute-Gloucester
Gloucester, Virginia, 23061
Site Public Contact, 757-534-6863, casey.morris@rivhs.com
Nemer J. El Mouallem
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
Banner North Colorado Medical Center
Greeley, Colorado, 80631
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
HaysMed
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Gary C. Doolittle
- Recruiting
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 570-459-2901, cancerresearch@geisinger.edu
Rajiv Panikkar
- Recruiting
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu
John K. Hill
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Site Public Contact, 218-283-9431
Bret E. Friday
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Stephanie Gilbertson-White
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Active, not recruiting
SSM Health Dean Medical Group - Janesville
Janesville, Wisconsin, 53546
- Recruiting
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, 37604
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Gary C. Doolittle
- Recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Site Public Contact, 336-718-8335, asmarrs@novanthealth.org
Judith O. Hopkins
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Michael O. Ojelabi
- Recruiting
Cancer Center of Acadiana
Lafayette, Louisiana, 70503
Site Public Contact, 337-289-8400
Steven J. Saccaro
- Suspended
Doctor's Hospital of Laredo
Laredo, Texas, 78041
- Recruiting
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011
Site Public Contact, 575-556-6545, Deborah.Brown@LPNT.net
Moises Harari-Turquie
- Recruiting
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG
Gary C. Doolittle
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Joseph D. Phillips
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu
Rajiv Panikkar
- Recruiting
CommonSpirit Saint Joseph Hospital - Lexington
Lexington, Kentucky, 40504
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
CommonSpirit Saint Joseph Medical Center - East Lexington
Lexington, Kentucky, 40509
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
CommonSpirit Saint Joseph Hospital London
London, Kentucky, 40741
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Active, not recruiting
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
SSM Health Dean Medical Group - South Madison Campus
Madison, Wisconsin, 53715
- Recruiting
Schoolcraft Memorial Hospital
Manistique, Michigan, 49854
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Maple Grove
Maple Grove, Minnesota, 55369
Site Public Contact, 952-993-1572, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
UP Health System Marquette
Marquette, Michigan, 49855
Site Public Contact, 906-225-4600, Dianna.Larson@mghs.org
Sheetal S. Acharya
- Recruiting
Sovah Health Martinsville
Martinsville, Virginia, 24112
Site Public Contact, 276-666-7489, sharon.hubbard@lpnt.net
Brandon Mullins
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Nour Daboul
- Recruiting
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
Site Public Contact, 336-718-8335, asmarrs@novanthealth.org
Judith O. Hopkins
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com
Jay W. Carlson
- Recruiting
Knox Community Hospital
Mount Vernon, Ohio, 43050
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
- Recruiting
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Augusto C. Ochoa
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Steven J. Saccaro
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
New Ulm Medical Center
New Ulm, Minnesota, 56073
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Active, not recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Vamsi K. Vasireddy
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Recruiting
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu
Gary C. Doolittle
- Suspended
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Nour Daboul
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Site Public Contact, 800-275-6401, cancerresearch@geisinger.edu
Rajiv Panikkar
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Princeton Community Hospital
Princeton, West Virginia, 24740
Site Public Contact, 304-487-7515
Nour Daboul
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 775-982-5050, Renown-CRD@renown.org
Max J. Coppes
- Recruiting
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Reid Health
Richmond, Indiana, 47374
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, 23249
Site Public Contact, 804-675-5646, Regina.McClung@va.gov
Sejal Kothadia
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Nemer J. El Mouallem
- Recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Memorial Hospital of Sweetwater County
Rock Springs, Wyoming, 82901
Site Public Contact, 307-352-8381, tharris@sweetwatermemorial.com
Banu E. Symington
- Recruiting
OSF Saint Anthony Medical Center
Rockford, Illinois, 61108
Site Public Contact, 815-227-2633
Shylendra B. Sreenivasappa
- Recruiting
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Site Public Contact, 573-458-6379
Jay W. Carlson
- Recruiting
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Site Public Contact, 573-458-7504, research@phelpshealth.org
Jay W. Carlson
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Joseph D. Phillips
- Recruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com
Jay W. Carlson
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Salina Regional Health Center
Salina, Kansas, 67401
Site Public Contact, 785-452-7038, mleepers@srhc.com
Gary C. Doolittle
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Low Country Cancer Care
Savannah, Georgia, 31404
Site Public Contact, 912-350-7887, Lorraine.OHara@hcahealthcare.com
James J. Burke
- Recruiting
Memorial Health University Medical Center
Savannah, Georgia, 31404
Site Public Contact, 912-350-7887, Lorraine.OHara@hcahealthcare.com
James J. Burke
- Recruiting
Community Medical Center
Scranton, Pennsylvania, 18510
Site Public Contact, 570-703-4768, cancerresearch@geisinger.edu
Rajiv Panikkar
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Site Public Contact, nemer.elmouallem@vcuhealth.org
Nemer J. El Mouallem
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
Site Public Contact, 417-269-4520
Jay W. Carlson
- Active, not recruiting
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Saint Helena Hospital
St. Helena, California, 94574
Site Public Contact, 707-967-3698
Ethan D. Schram
- Recruiting
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Lakeview Hospital
Stillwater, Minnesota, 55082
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Site Public Contact, 701-364-6272
Bret E. Friday
- Recruiting
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606
Site Public Contact, 785-270-4939
Brandon R. Weckbaugh
- Recruiting
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Site Public Contact, 785-295-8000
Gary C. Doolittle
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
The Carle Foundation Hospital
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Vamsi K. Vasireddy
- Recruiting
Inspira Medical Center Vineland
Vineland, New Jersey, 08360
Site Public Contact, 856-641-7933
Mylene S. Go
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
Sentara Princess Anne Hospital
Virginia Beach, Virginia, 23456
- Recruiting
Ridgeview Medical Center
Waconia, Minnesota, 55387
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Aspirus Cancer Care-Wausau
Wausau, Wisconsin, 54401
Site Public Contact, 877-405-6866
Andrew J. Huang
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Kerri McGovern
- Recruiting
The Iowa Clinic PC
West Des Moines, Iowa, 50266
Site Public Contact, 515-875-9815
Seema Harichand-Herdt
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Rajiv Panikkar
- Recruiting
Rice Memorial Hospital
Willmar, Minnesota, 56201
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Site Public Contact, 715-422-7718
Andrew J. Huang
- Recruiting
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Vamsi K. Vasireddy
About this study
Official title: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Smoking Cessation Intervention, Health Promotion and Education, Informational Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation InterventionBehavioural
Participate in schedule gradual reduction program
Health Promotion and EducationOther
Receive cessation support messages
Informational InterventionOther
Receive NCI's Clearing the Air booklet
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (SGR program, text messages) | Experimental | 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. Receives: Behavioral: Smoking Cessation Intervention; Other: Health Promotion and Education; Other: Questionnaire Administration |
| Group II (booklet) | Active comparator | Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. Receives: Other: Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months post-quit date
Secondary outcomes (1)
Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date
At a given measurement time point, the patient-reported overall QoL score will be obtained from a linear analogue self-assessment scale (LASA), which is an 11-point scoring scale (0, 1, …, 10) where 0 indicates as bad as can be and 10 indicates as good as can be. A linear mixed model will be used to compare the average difference between the randomized arms across the two post-randomization time points after adjusting for the baseline overall QoL score, 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.
Measured: Up to 6-months post-quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Apr 2022
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Devon Noonan, PhD, MPH, FNP-BC, Study chair, Duke School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008848
- Sponsor's protocol ID
- A211901
- Other IDs
- NCI-2021-03543, UG1CA189823
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
- ClinicalTrials.gov ID
- NCT05008848
- Acronym / sponsor ID
- A211901
- Conditions
- Cigarette Smoking-Related Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Sep 2027 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (SGR program, text messages) | Experimental | Behavioral: Smoking Cessation Intervention, Other: Health Promotion and Education, Other: Questionnaire AdministrationPatients 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 (booklet) | Active comparator | Other: Informational InterventionPatients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have a cancer diagnosis within the past 10 years
- 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) and/or a Rural-Urban Commuting area code of 4-10 and/or as defined by the Office of Management and Budget as a non-rural county large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with rural-urban commuting area (RUCA) codes 2-3; and outlying metro counties without a UA. The RUCC code and RUCA (4-10) codes can be checked at: https://www.ruralhealthinfo.org/am-i-rural. Those with RUCA codes of 2-3 can be checked at https://data.hrsa.gov/tools/rural-health for eligibility
- Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation InterventionParticipate in schedule gradual reduction program | Behavioural | Group I (SGR program, text messages) |
| Health Promotion and EducationReceive cessation support messages | Other | Group I (SGR program, text messages) |
| Informational InterventionReceive NCI's Clearing the Air booklet | Other | Group II (booklet) |
| Questionnaire AdministrationAncillary studies | Other | Group I (SGR program, text messages) |
Primary outcome
Biochemically validated tobacco cessation
Time frame: Up to 6 months post-quit date
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devon Noonan, PhD, MPH, FNP-BC study chair
Duke School of Nursing
223 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Smoking Cessation Intervention, Health Promotion and Education and Informational Intervention in people with Cigarette Smoking-Related Carcinoma, run by Alliance for Clinical Trials in Oncology at 223 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 223 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devon Noonan, PhD, MPH, FNP-BC (919-613-9130, devon.noonan@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated tobacco cessation (time frame: Up to 6 months post-quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.