About this trial
Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age.
≥100 lifetime cigarettes.
English-speaking.
Report smoking ≥ 1 cigarette in past 30 days.
Disqualifiers
Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
Currently pregnant or breastfeeding.
Trial design
Sequential
Treatments tested in this trial
Quitline Treatment (QT)
Other interventionTobacco Free Florida Quitline. 10-week supply of Combination Nicotine Replacement Therapy (NRT).
App-based Treatment (mHealth)
Other interventionFully automated digitally-delivered smoking cessation intervention targeted to cancer patients. 10-week supply of Combination Nicotine Replacement Therapy (NRT).
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: Screening
Our screening process will be deemed feasible if: 1) ≥ 90% of patients complete the screener, 2) the proportion of patients identified as smokers meets or exceeds the historical self-reported proportions at each institution, 3) the program correctly identifies eligible participants and subsequently presents automated advice to quit, 4) it offers an opportunity to enroll in smoking cessation treatment, and 5) ≥ 30% of eligible patients enroll in treatment.
Usability: mHealth
Usability will be measured 2 ways: I) ≥ 80% will score ≥ 70 on the Systems Usability Scale (SUS), 10-item measure, (scores 0-100) assessing learnability and usability. II) ≥ 80% rate app as easy to use (dichotomous Y/N).
Acceptability/Satisfaction: mHealth
Acceptability/Satisfaction will be measured 4 ways: I) ≥ 80 will score mean ≥ 3.0 Client Satisfaction Questionnaire (CSQ), 8-item measure, (1-4 scale). II) ≥ 80% mostly or extremely satisfied with app. III) ≥ 80% would recommend this app to a friend to quit smoking (dichotomous Y/N). IV) ≥ 80% rate quality of intervention as good or excellent.
Sponsors and contacts
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Florida Biomedical Research Program - James & Esther King
Collaborator