High-Risk Cancer Clinical Trial
Official title:
Adjunctive Smart Phone Based Smoking Cessation Treatment
Participants will be recruited for the current study during their initial orientation visit to the Parkland Health and Hospital System, Stop Smoking Class and Clinic every Monday morning. Individuals who are interested and eligible for participation in this study will receive uC (Parkland smoking cessation program), plus a tailored, adaptive, smart phone delivered smoking cessation intervention. Participants will be followed weekly from 1 week pre-quit through 4 weeks post-quit. all participants will be asked to attend 6 weekly visits, 4 of these visits will include a thorough assessment that may be completed either before or after their scheduled Parkland treatment appointments. All participants will receive a smartphone at the 1 week pre-quit visit and they will be asked to carry it with them at all times. Participants will complete eMa assessments 5 times per day (4 random assessments + 1 daily dairy) for three consecutive weeks. Geographic location coordinates will be captured during each eMa assessment to link characteristics of the neighborhood environment (e.g., neighborhood socioeconomic status, proximity to tobacco outlets) with cessation-related outcomes. Participants will be compensated upon the return of the smartphone at visit 4 (2 weeks post-quit). Participants will be asked to attend a follow-up visit 12 weeks after their quit date. At this visit, participants will complete additional questionnaires and their smoking status will be assessed. Expired carbon monoxide and weight will also be measured.
Research Supporting Study Objectives. Tobacco use is the leading cause of preventable death
in the U.S. Over 443,000 deaths per year are attributable to smoking, with the leading causes
of smoking-attributable death being cancer, cardiovascular diseases, and respiratory disease.
Although the prevalence of smoking has declined to 20.6% among U.S. adults, 31.1% of those
living in poverty are currently smoking. Numerous studies have shown that low SES and
financial strain are associated with a reduced likelihood of smoking cessation. As such, lung
cancer incidence is far greater among those with low education and who are living in poverty,
relative to their higher SES counterparts. Although individuals of low SES are just as likely
to attempt smoking cessation, they are less likely to succeed. As such, smoking cessation
interventions for low SES populations have had limited success (e.g., biologically confirmed
7-day point prevalence abstinence rates of 7-13% at 6-month follow-up. Innovative smoking
cessation interventions are needed to help reduce the rate of smoking in socioeconomically
disadvantaged populations of smokers.
Ecological Momentary Assessment and Smoking Cessation Treatments. To date, most studies that
have examined smoking and smoking cessation in socioeconomically disadvantaged smokers have
used focus groups or traditional lab/clinic based assessment methodology. In the latter
scenario, study participants arrive at a lab or clinic for their baseline visit and are asked
to answer questions about their "average" or "recent" (e.g., over the past 2 weeks) mood,
level of stress, and smoking urges. Participants return to the lab/clinic for follow-up
visits and are asked to report thoughts, feelings, and activities that occurred weeks or even
months earlier (e.g., "How stressed were you when you smoked your first cigarette after your
quit date?"). This type of assessment methodology may result in biased and/or inaccurate
estimates due to recall biases and errors in memory and only offers a gross understanding of
how cessation symptoms effect smoking lapses and relapse. A more nuanced picture of these
symptoms may offer important insights that may be used to create or improve cessation
interventions for socioeconomically disadvantaged smokers, who face unique and substantial
challenges in quitting smoking.
Ecological momentary assessment (EMA), in which handheld devices (e.g., smart phones) are
used to capture moment to moment experience, is currently the most accurate way to measure
phenomena in real time in natural settings. EMAs are often used to assess individuals at
multiple time points throughout a day. Thus, momentary changes in key variables can be
tracked and potentially used to initiate novel interventions. EMA research may facilitate a
better understanding of the mechanisms involved in successful cessation attempts, those
affecting smoking lapses, and those implicated in the transition from lapse to relapse.
Although multiple studies have identified momentary predictors of smoking relapse to our
knowledge, no studies have used a participant's responses to EMAs to automatically prompt
tailored smoking cessation interventions. Using smart phones to detect high relapse risk
situations and automatically deliver tailored smoking cessation treatments may help
socioeconomically disadvantaged smokers quit.
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