This phase III trial compares the effect of text-based cessation intervention to manuals in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarettes use to zero and may be effective in quitting smoking.
Additional locations may be listed on ClinicalTrials.gov for NCT05008848 .
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PRIMARY OBJECTIVE:
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 Global quality of life (QOL) at 30-days post-quit date and six-months post-quit date.
EXPLORATORY OBJECTIVES:
I. Compare changes in the 5 LASA scales between the SGR group and the control group.
II. Compare changes in the total score obtained from the Fagerstrom Test for Nicotine Dependence (FTND) between the SGR group and the control group.
III. Describe intervention adherence (response to SGR texts) and intervention interaction (number of times participants text the system for support) for patients randomized to the intervention group.
IV. Explore the predictive role of degree of urbanization (e.g. Rural Urban Continuum Code [RUCC] 4-9) on smoking cessation.
V. Explore the effects of the SGR intervention and control intervention on other health behaviors (sleep, alcohol use, physical activity and fruit and vegetable intake).
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 30 days and 6 months.
Lead Organization Alliance for Clinical Trials in Oncology
Principal Investigator Devon Noonan