NCT05008848 · Alliance for Clinical Trials in Oncology
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Smoking Cessation Intervention
Participate in schedule gradual reduction program
OTHER
Health Promotion and Education
Receive cessation support messages
OTHER
Informational Intervention
Receive NCI's Clearing the Air booklet
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 impa
Where
- Kingman, Arizona
- Fort Smith, Arkansas
- St. Helena, California
- Greeley, Colorado
- Loveland, Colorado
- Gainesville, Florida
- Braselton, Georgia
- Gainesville, Georgia
- Savannah, Georgia
- Boise, Idaho
- Caldwell, Idaho
- Coeur d'Alene, Idaho
And 177 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations