Clinical trial NCT05008848: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Official title: Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemically validated tobacco cessation
timeFrame: Up to 6 months post-quit date
Secondary outcomes:
measure: Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date
timeFrame: Up to 6-months post-quit date
Other outcomes:
Locations:
city: Kingman
country: United States
facility: Kingman Regional Medical Center
state: Arizona
city: Fort Smith
country: United States
facility: Mercy Hospital Fort Smith
state: Arkansas
city: Saint Helena
country: United States
facility: Saint Helena Hospital
state: California
city: Greeley
country: United States
facility: Banner North Colorado Medical Center
state: Colorado
city: Loveland
country: United States
facility: Banner McKee Medical Center
state: Colorado
city: Savannah
country: United States
facility: Low Country Cancer Care
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center-Boise
state: Idaho
city: Caldwell
country: United States
facility: Saint Alphonsus Cancer Care Center-Caldwell
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Health - Coeur d'Alene
state: Idaho
city: Nampa
country: United States
facility: Saint Alphonsus Cancer Care Center-Nampa
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Clinic Cancer Services - Post Falls
state: Idaho
city: Sandpoint
country: United States
facility: Kootenai Clinic Cancer Services - Sandpoint
state: Idaho
city: Aurora
country: United States
facility: Rush - Copley Medical Center
state: Illinois
city: Bloomington
country: United States
facility: Carle BroMenn Outpatient Center
state: Illinois
city: Bloomington
country: United States
facility: Illinois CancerCare-Bloomington
state: Illinois
city: Canton
country: United States
facility: Illinois CancerCare-Canton
state: Illinois
city: Carthage
country: United States
facility: Illinois CancerCare-Carthage
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Centralia
country: United States
facility: Saint Mary's Hospital
state: Illinois
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Dixon
country: United States
facility: Illinois CancerCare-Dixon
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Eureka
country: United States
facility: Illinois CancerCare-Eureka
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare-Galesburg
state: Illinois
city: Kewanee
country: United States
facility: Illinois CancerCare-Kewanee Clinic
state: Illinois
city: Macomb
country: United States
facility: Illinois CancerCare-Macomb
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Mount Vernon
country: United States
facility: SSM Health Good Samaritan
state: Illinois
city: Normal
country: United States
facility: Carle BroMenn Medical Center
state: Illinois
city: Normal
country: United States
facility: Carle Cancer Institute Normal
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare-Ottawa Clinic
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare-Pekin
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Peru
country: United States
facility: Illinois CancerCare-Peru
state: Illinois
city: Princeton
country: United States
facility: Illinois CancerCare-Princeton
state: Illinois
city: Rockford
country: United States
facility: OSF Saint Anthony Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Springfield Memorial Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: Washington
country: United States
facility: Illinois CancerCare - Washington
state: Illinois
city: Yorkville
country: United States
facility: Rush-Copley Healthcare Center
state: Illinois
city: Bettendorf
country: United States
facility: University of Iowa Healthcare Cancer Services Quad Cities
state: Iowa
city: Carroll
country: United States
facility: Saint Anthony Regional Hospital
state: Iowa
city: Cedar Rapids
country: United States
facility: Saint Luke's Hospital
state: Iowa
city: Cedar Rapids
country: United States
facility: Oncology Associates at Mercy Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: UI Health Care Mission Cancer and Blood - Des Moines Clinic
state: Iowa
city: Des Moines
country: United States
facility: Broadlawns Medical Center
state: Iowa
city: Fort Dodge
country: United States
facility: Trinity Regional Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa/Holden Comprehensive Cancer Center
state: Iowa
city: Hays
country: United States
facility: HaysMed
state: Kansas
city: Lawrence
country: United States
facility: Lawrence Memorial Hospital
state: Kansas
city: Olathe
country: United States
facility: The University of Kansas Cancer Center - Olathe
state: Kansas
city: Salina
country: United States
facility: Salina Regional Health Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Cancer Center / Stormont Vail Health
state: Kansas
city: Topeka
country: United States
facility: University of Kansas Health System Saint Francis Campus
state: Kansas
city: Bardstown
country: United States
facility: Flaget Memorial Hospital
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Hospital
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Hospital East
state: Kentucky
city: London
country: United States
facility: Saint Joseph London
state: Kentucky
city: Lafayette
country: United States
facility: Cancer Center of Acadiana
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Escanaba
country: United States
facility: OSF Saint Francis Hospital and Medical Group
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health Grand Rapids Hospitals - Butterworth Hospital
state: Michigan
city: Marquette
country: United States
facility: UP Health System Marquette
state: Michigan
city: Reed City
country: United States
facility: Corewell Health Reed City Hospital
state: Michigan
city: Saint Joseph
country: United States
facility: Corewell Health Lakeland Hospitals - Saint Joseph Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Brainerd
country: United States
facility: Essentia Health Saint Joseph's Medical Center
state: Minnesota
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Deer River
country: United States
facility: Essentia Health - Deer River Clinic
state: Minnesota
city: Detroit Lakes
country: United States
facility: Essentia Health Saint Mary's - Detroit Lakes Clinic
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Cancer Center
state: Minnesota
city: Duluth
country: United States
facility: Saint Luke's Hospital of Duluth
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Ely
country: United States
facility: Essentia Health - Ely Clinic
state: Minnesota
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Essentia Health Hibbing Clinic
state: Minnesota
city: International Falls
country: United States
facility: Essentia Health - International Falls Clinic
state: Minnesota
city: Maple Grove
country: United States
facility: Fairview Clinics and Surgery Center Maple Grove
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Park Rapids
country: United States
facility: Essentia Health - Park Rapids
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Sandstone
country: United States
facility: Essentia Health Sandstone
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Virginia
country: United States
facility: Essentia Health Virginia Clinic
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: Ballwin
country: United States
facility: Saint Louis Cancer and Breast Institute-Ballwin
state: Missouri
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
city: Farmington
country: United States
facility: Parkland Health Center - Farmington
state: Missouri
city: Kansas City
country: United States
facility: University Health Truman Medical Center
state: Missouri
city: Osage Beach
country: United States
facility: Lake Regional Hospital
state: Missouri
city: Rolla
country: United States
facility: Mercy Clinic-Rolla-Cancer and Hematology
state: Missouri
city: Rolla
country: United States
facility: Phelps Health Delbert Day Cancer Institute
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Sainte Genevieve
country: United States
facility: Sainte Genevieve County Memorial Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Springfield
country: United States
facility: CoxHealth South Hospital
state: Missouri
city: Sullivan
country: United States
facility: Missouri Baptist Sullivan Hospital
state: Missouri
city: Sunset Hills
country: United States
facility: BJC Outpatient Center at Sunset Hills
state: Missouri
city: Anaconda
country: United States
facility: Community Hospital of Anaconda
state: Montana
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Great Falls
country: United States
facility: Benefis Sletten Cancer Institute
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Kalispell
country: United States
facility: Logan Health Medical Center
state: Montana
city: Missoula
country: United States
facility: Community Medical Center
state: Montana
city: Kearney
country: United States
facility: CHI Health Good Samaritan
state: Nebraska
city: Carson City
country: United States
facility: Carson Tahoe Regional Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
state: New Hampshire
city: Vineland
country: United States
facility: Inspira Medical Center Vineland
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Las Cruces
country: United States
facility: Memorial Medical Center-Las Cruces
state: New Mexico
city: Cooperstown
country: United States
facility: Mary Imogene Bassett Hospital
state: New York
city: Clemmons
country: United States
facility: Novant Health Colon and Rectal Clinic
state: North Carolina
city: Clinton
country: United States
facility: Southeastern Medical Oncology Center-Clinton
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center-Goldsboro
state: North Carolina
city: Greensboro
country: United States
facility: Novant Health Breast Surgery - Greensboro
state: North Carolina
city: Hendersonville
country: United States
facility: Margaret R Pardee Memorial Hospital
state: North Carolina
city: Jacksonville
country: United States
facility: Southeastern Medical Oncology Center-Jacksonville
state: North Carolina
city: Kernersville
country: United States
facility: Novant Health Cancer Institute - Kernersville
state: North Carolina
city: Mount Airy
country: United States
facility: Novant Health Cancer Institute - Mount Airy
state: North Carolina
city: Thomasville
country: United States
facility: Novant Health Cancer Institute - Thomasville
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Essentia Health Cancer Center-South University Clinic
state: North Dakota
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Perrysburg
country: United States
facility: Mercy Health - Perrysburg Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - Saint Anne Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Ontario
country: United States
facility: Saint Alphonsus Cancer Care Center-Ontario
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hazleton
country: United States
facility: Geisinger Medical Center-Cancer Center Hazleton
state: Pennsylvania
city: Lewisburg
country: United States
facility: Geisinger Medical Oncology-Lewisburg
state: Pennsylvania
city: Pottsville
country: United States
facility: Geisinger Cancer Services-Pottsville
state: Pennsylvania
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Johnson City
country: United States
facility: Regional Cancer Center at Johnson City Medical Center
state: Tennessee
city: Kingsport
country: United States
facility: Ballad Health Cancer Care - Kingsport
state: Tennessee
city: Abilene
country: United States
facility: Hendrick Medical Center
state: Texas
city: Edinburg
country: United States
facility: STCC at DHR Health Institute for Research and Development
state: Texas
city: Laredo
country: United States
facility: Doctor's Hospital of Laredo
state: Texas
city: Saint Johnsbury
country: United States
facility: Dartmouth Cancer Center - North
state: Vermont
city: Bristol
country: United States
facility: Ballad Health Cancer Care - Bristol
state: Virginia
city: Chesapeake
country: United States
facility: Chesapeake Regional Medical Center
state: Virginia
city: Martinsville
country: United States
facility: Sovah Health Martinsville
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Administration Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: South Hill
country: United States
facility: VCU Community Memorial Health Center
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Princess Anne Hospital
state: Virginia
city: Ashland
country: United States
facility: Duluth Clinic Ashland
state: Wisconsin
city: Baraboo
country: United States
facility: SSM Health Dean Medical Group - Baraboo
state: Wisconsin
city: Eau Claire
country: United States
facility: HSHS Sacred Heart Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Saint Mary's
state: Wisconsin
city: Janesville
country: United States
facility: SSM Health Dean Medical Group - Janesville
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Madison
country: United States
facility: SSM Health Dean Medical Group - South Madison Campus
state: Wisconsin
city: New Richmond
country: United States
facility: Cancer Center of Western Wisconsin
state: Wisconsin
city: Oconto Falls
country: United States
facility: Saint Vincent Hospital Cancer Center at Oconto Falls
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay
state: Wisconsin
city: Superior
country: United States
facility: Essentia Health Saint Mary's Hospital - Superior
state: Wisconsin
city: Rock Springs
country: United States
facility: Memorial Hospital of Sweetwater County
state: Wyoming
Study officials:
affiliation: Duke School of Nursing
name: Devon Noonan, PhD, MPH, FNP-BC
role: STUDY_CHAIR
References: