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.
Have a cancer diagnosis within the past 10 years
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) and/or a Rural-Urban Commuting area code of 4-10 and/or as defined by the Office of Management and Budget as a non-rural county large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with rural-urban commuting area (RUCA) codes 2-3; and outlying metro counties without a UA. The RUCC code and RUCA (4-10) codes can be checked at: https://www.ruralhealthinfo.org/am-i-rural. Those with RUCA codes of 2-3 can be checked at https://data.hrsa.gov/tools/rural-health for eligibility
None
Parallel
Smoking Cessation Intervention
BehavioralParticipate in schedule gradual reduction program
Health Promotion and Education
Other interventionReceive cessation support messages
Informational Intervention
Other interventionReceive NCI's Clearing the Air booklet
Questionnaire Administration
Other interventionAncillary 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.
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.
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Alliance for Clinical Trials in Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
