A Phase 3 interventional study of Smoking Cessation Intervention and Health Promotion and Education in Cigarette Smoking-Related Carcinoma, sponsored by Alliance for Clinical Trials in Oncology. Recruiting at 224 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Prevention
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.
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.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 600 is above the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Have a cancer diagnosis within the past 10 years
* Note: Patients with ductal carcinoma in situ (DCIS) are eligible and patients currently receiving curative treatment are eligible
Currently smokes >= 5 cigarettes daily
* Note: Participants who smoke cigarettes and vape are eligible. Those who only vape are ineligible
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.
Behavioral: Smoking Cessation Intervention · Other: Health Promotion and Education · Other: Questionnaire Administration
Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.
Other: Informational Intervention
Participate in schedule gradual reduction program
Receive cessation support messages
Receive NCI's Clearing the Air booklet
Ancillary studies
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.
Time frame: Up to 6 months post-quit date
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.
Time frame: Up to 6-months post-quit date
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Plan to share: Yes
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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