Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
3 other identifiers
interventional
600
1 country
207
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2022
Longer than P75 for phase_3
207 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 2, 2026
April 1, 2026
4.9 years
August 10, 2021
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Up to 6-months post-quit date
Study Arms (2)
Group I (SGR program, text messages)
EXPERIMENTALPatients 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 COMPARATORPatients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.
Interventions
Participate in schedule gradual reduction program
Receive cessation support messages
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Psychiatric illness which would prevent the patient from giving informed consent
- Patients with impaired decision-making capacity are not eligible for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (207)
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
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
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Saint Joseph 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
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
Mercy Hospital
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
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 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
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
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
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
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
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
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
Memorial Hospital of Sweetwater County
Rock Springs, Wyoming, 82901, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Devon Noonan, PhD, MPH, FNP-BC
Duke School of Nursing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 17, 2021
Study Start
April 1, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share