Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
- Conditions
- Cigarette Smoking-Related Carcinoma
- Interventions
- Other: Informational InterventionBehavioral: Smoking Cessation InterventionOther: Health Promotion and EducationOther: Questionnaire Administration
- Registration Number
- NCT05008848
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (SGR program, text messages) Health Promotion and Education 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 I (SGR program, text messages) Questionnaire Administration 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 (booklet) Informational Intervention Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. Group I (SGR program, text messages) Smoking Cessation Intervention 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.
- Primary Outcome Measures
Name Time Method Biochemically validated tobacco cessation 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (191)
Saint Mary's Hospital
🇺🇸Centralia, Illinois, United States
Kingman Regional Medical Center
🇺🇸Kingman, Arizona, United States
Mercy Hospital Fort Smith
🇺🇸Fort Smith, Arkansas, United States
Saint Helena Hospital
🇺🇸Saint Helena, California, United States
Banner North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Banner McKee Medical Center
🇺🇸Loveland, Colorado, United States
Low Country Cancer Care
🇺🇸Savannah, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
🇺🇸Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
🇺🇸Coeur d'Alene, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
🇺🇸Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
🇺🇸Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
🇺🇸Sandpoint, Idaho, United States
Rush - Copley Medical Center
🇺🇸Aurora, Illinois, United States
Illinois CancerCare-Canton
🇺🇸Canton, Illinois, United States
Carle BroMenn Outpatient Center
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Carthage
🇺🇸Carthage, Illinois, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
SSM Health Good Samaritan
🇺🇸Mount Vernon, Illinois, United States
Centralia Oncology Clinic
🇺🇸Centralia, Illinois, United States
Crossroads Cancer Center
🇺🇸Effingham, Illinois, United States
Carle BroMenn Medical Center
🇺🇸Normal, Illinois, United States
Carle Cancer Institute Normal
🇺🇸Normal, Illinois, United States
Cancer Care Center of O'Fallon
🇺🇸O'Fallon, Illinois, United States
Carle at The Riverfront
🇺🇸Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
🇺🇸Decatur, Illinois, United States
Illinois CancerCare-Eureka
🇺🇸Eureka, Illinois, United States
Illinois CancerCare-Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
Illinois CancerCare-Dixon
🇺🇸Dixon, Illinois, United States
Illinois CancerCare-Galesburg
🇺🇸Galesburg, Illinois, United States
Carle Physician Group-Effingham
🇺🇸Effingham, Illinois, United States
Illinois CancerCare-Macomb
🇺🇸Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
🇺🇸Mattoon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare-Pekin
🇺🇸Pekin, Illinois, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Illinois CancerCare-Peru
🇺🇸Peru, Illinois, United States
Illinois CancerCare-Princeton
🇺🇸Princeton, Illinois, United States
OSF Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Springfield Memorial Hospital
🇺🇸Springfield, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
The Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Illinois CancerCare - Washington
🇺🇸Washington, Illinois, United States
Rush-Copley Healthcare Center
🇺🇸Yorkville, Illinois, United States
University of Iowa Healthcare Cancer Services Quad Cities
🇺🇸Bettendorf, Iowa, United States
Saint Anthony Regional Hospital
🇺🇸Carroll, Iowa, United States
Saint Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
🇺🇸Des Moines, Iowa, United States
Broadlawns Medical Center
🇺🇸Des Moines, Iowa, United States
Trinity Regional Medical Center
🇺🇸Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
HaysMed
🇺🇸Hays, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
The University of Kansas Cancer Center - Olathe
🇺🇸Olathe, Kansas, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
🇺🇸Topeka, Kansas, United States
University of Kansas Health System Saint Francis Campus
🇺🇸Topeka, Kansas, United States
Flaget Memorial Hospital
🇺🇸Bardstown, Kentucky, United States
Saint Joseph Hospital
🇺🇸Lexington, Kentucky, United States
Saint Joseph Hospital East
🇺🇸Lexington, Kentucky, United States
Saint Joseph London
🇺🇸London, Kentucky, United States
Cancer Center of Acadiana
🇺🇸Lafayette, Louisiana, United States
Louisiana State University Health Science Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
OSF Saint Francis Hospital and Medical Group
🇺🇸Escanaba, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
UP Health System Marquette
🇺🇸Marquette, Michigan, United States
Corewell Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
🇺🇸Saint Joseph, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Essentia Health Saint Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Minnesota Oncology - Burnsville
🇺🇸Burnsville, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
🇺🇸Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
🇺🇸Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
🇺🇸Duluth, Minnesota, United States
Saint Luke's Hospital of Duluth
🇺🇸Duluth, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Essentia Health - Ely Clinic
🇺🇸Ely, Minnesota, United States
Unity Hospital
🇺🇸Fridley, Minnesota, United States
Essentia Health Hibbing Clinic
🇺🇸Hibbing, Minnesota, United States
Essentia Health - International Falls Clinic
🇺🇸International Falls, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
🇺🇸Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Monticello Cancer Center
🇺🇸Monticello, Minnesota, United States
New Ulm Medical Center
🇺🇸New Ulm, Minnesota, United States
Essentia Health - Park Rapids
🇺🇸Park Rapids, Minnesota, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Essentia Health Sandstone
🇺🇸Sandstone, Minnesota, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Essentia Health Virginia Clinic
🇺🇸Virginia, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Fairview Lakes Medical Center
🇺🇸Wyoming, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin
🇺🇸Ballwin, Missouri, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington
🇺🇸Farmington, Missouri, United States
University Health Truman Medical Center
🇺🇸Kansas City, Missouri, United States
Lake Regional Hospital
🇺🇸Osage Beach, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
🇺🇸Rolla, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
SSM Health Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital South
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital
🇺🇸Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Missouri Baptist Sullivan Hospital
🇺🇸Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
🇺🇸Sunset Hills, Missouri, United States
Benefis Sletten Cancer Institute
🇺🇸Great Falls, Montana, United States
Community Hospital of Anaconda
🇺🇸Anaconda, Montana, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Bozeman Health Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Logan Health Medical Center
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Scranton, Pennsylvania, United States
CHI Health Good Samaritan
🇺🇸Kearney, Nebraska, United States
Carson Tahoe Regional Medical Center
🇺🇸Carson City, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Inspira Medical Center Vineland
🇺🇸Vineland, New Jersey, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Memorial Medical Center-Las Cruces
🇺🇸Las Cruces, New Mexico, United States
Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
Novant Health Colon and Rectal Clinic
🇺🇸Clemmons, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
🇺🇸Clinton, North Carolina, United States
Durham VA Medical Center
🇺🇸Durham, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
🇺🇸Goldsboro, North Carolina, United States
Novant Health Breast Surgery - Greensboro
🇺🇸Greensboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
🇺🇸Jacksonville, North Carolina, United States
Novant Health Cancer Institute - Kernersville
🇺🇸Kernersville, North Carolina, United States
Novant Health Cancer Institute - Mount Airy
🇺🇸Mount Airy, North Carolina, United States
Novant Health Cancer Institute - Thomasville
🇺🇸Thomasville, North Carolina, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Essentia Health Cancer Center-South University Clinic
🇺🇸Fargo, North Dakota, United States
Strecker Cancer Center-Belpre
🇺🇸Belpre, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Mercy Health - Perrysburg Hospital
🇺🇸Perrysburg, Ohio, United States
Mercy Health - Saint Anne Hospital
🇺🇸Toledo, Ohio, United States
Mercy Hospital Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Ontario
🇺🇸Ontario, Oregon, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
🇺🇸Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
🇺🇸Lewisburg, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Regional Cancer Center at Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
Ballad Health Cancer Care - Kingsport
🇺🇸Kingsport, Tennessee, United States
Hendrick Medical Center
🇺🇸Abilene, Texas, United States
STCC at DHR Health Institute for Research and Development
🇺🇸Edinburg, Texas, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
Dartmouth Cancer Center - North
🇺🇸Saint Johnsbury, Vermont, United States
Ballad Health Cancer Care - Bristol
🇺🇸Bristol, Virginia, United States
Chesapeake Regional Medical Center
🇺🇸Chesapeake, Virginia, United States
Sovah Health Martinsville
🇺🇸Martinsville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Hunter Holmes McGuire Veterans Administration Medical Center
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
VCU Community Memorial Health Center
🇺🇸South Hill, Virginia, United States
Sentara Princess Anne Hospital
🇺🇸Virginia Beach, Virginia, United States
Duluth Clinic Ashland
🇺🇸Ashland, Wisconsin, United States
SSM Health Dean Medical Group - Baraboo
🇺🇸Baraboo, Wisconsin, United States
HSHS Sacred Heart Hospital
🇺🇸Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
🇺🇸Green Bay, Wisconsin, United States
SSM Health Dean Medical Group - Janesville
🇺🇸Janesville, Wisconsin, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
SSM Health Dean Medical Group - South Madison Campus
🇺🇸Madison, Wisconsin, United States
Cancer Center of Western Wisconsin
🇺🇸New Richmond, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Essentia Health Saint Mary's Hospital - Superior
🇺🇸Superior, Wisconsin, United States
Memorial Hospital of Sweetwater County
🇺🇸Rock Springs, Wyoming, United States