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NCT05008848 Clinical Trial

Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05008848
Other study ID # A211901
Secondary ID NCI-2021-03543UG
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2022
Est. completion date November 2025

Study information
Verified date April 2024
Source Alliance for Clinical Trials in Oncology
Contact Devon Noonan, PhD, MPH, FNP-BC
Phone 919-613-9130
Email devon.noonan@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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 information / eligibility
Status Recruiting
Enrollment 600
Est. completion date November 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment - Not currently on hospice - Currently smokes >= 5 cigarettes daily - Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9) - Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial - Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program - Patient has a cell phone or smart phone device with texting ability - In order to complete the mandatory patient-completed measures, participants must be able to speak and read English - Age >= 18 years - Participant must be willing to provide a urine sample. Exclusion Criteria: - Psychiatric illness which would prevent the patient from giving informed consent - Patients with impaired decision-making capacity are not eligible for this study.

Study Design

Related Conditions & MeSH terms

  • Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Smoking Cessation Intervention
Participate in schedule gradual reduction program
Other:
• Health Promotion and Education
Receive cessation support messages
• Informational Intervention
Receive NCI's Clearing the Air booklet
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Community Hospital of Anaconda Anaconda Montana
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States SSM Health Dean Medical Group - Baraboo Baraboo Wisconsin
United States Flaget Memorial Hospital Bardstown Kentucky
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Billings Clinic Cancer Center Billings Montana
United States Bromenn Lifecare Center Bloomington Illinois
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Bozeman Deaconess Hospital Bozeman Montana
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Saint Anthony Regional Hospital Carroll Iowa
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States Illinois CancerCare-Carthage Carthage Illinois
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Saint Luke's Hospital Cedar Rapids Iowa
United States Centralia Oncology Clinic Centralia Illinois
United States Chesapeake Regional Medical Center Chesapeake Virginia
United States Adena Regional Medical Center Chillicothe Ohio
United States Novant Health Colon and Rectal Clinic Clemmons North Carolina
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Mercy Hospital Coon Rapids Minnesota
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Illinois CancerCare-Dixon Dixon Illinois
United States Saint Luke's Hospital of Duluth Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States Parkland Health Center - Farmington Farmington Missouri
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Novant Health Breast Surgery - Greensboro Greensboro North Carolina
United States HaysMed University of Kansas Health System Hays Kansas
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States SSM Health Dean Medical Group - Janesville Janesville Wisconsin
United States Kalispell Regional Medical Center Kalispell Montana
United States Truman Medical Centers Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Novant Health Cancer Institute - Kernersville Kernersville North Carolina
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Doctor's Hospital of Laredo Laredo Texas
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States Lawrence Memorial Hospital Lawrence Kansas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph London London Kentucky
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Dean Hematology and Oncology Clinic Madison Wisconsin
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 Sovah Health Martinsville Martinsville Virginia
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Community Medical Hospital Missoula Montana
United States Monticello Cancer Center Monticello Minnesota
United States Novant Health Cancer Institute - Mount Airy Mount Airy North Carolina
United States Knox Community Hospital Mount Vernon Ohio
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Bromenn Regional 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 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States Olathe Health Cancer Center Olathe Kansas
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Lake Regional Hospital Osage Beach Missouri
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Corewell Health Reed City Hospital Reed City Michigan
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Memorial Hospital of Sweetwater County Rock Springs Wyoming
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States SSM Health Saint Louis University Hospital Saint Louis Missouri
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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Low Country Cancer Care Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States Community Medical Center Scranton Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States VCU Community Memorial Health Center South Hill Virginia
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Lakeview Hospital Stillwater Minnesota
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Novant Health Cancer Institute - Thomasville Thomasville North Carolina
United States Mercy Health - Saint Anne Hospital Toledo Ohio
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 Munson Medical Center Traverse City Michigan
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Sentara Princess Anne Hospital Virginia Beach Virginia
United States Ridgeview Medical Center Waconia Minnesota
United States Illinois CancerCare - Washington Washington Illinois
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Novant Health Forsyth Medical Center Winston-Salem North Carolina
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Rush-Copley Healthcare Center Yorkville Illinois

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. Up to 6-months post-quit date
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