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Development of a smartphone application integrating financial coaching and smoking cessation support for adults with financial hardship: protocol for a 3-phase pilot study
ABSTRACT
Background:
Adults experiencing financial hardship continue to have a high smoking prevalence and bear higher burden of tobacco-related illness. Evidence suggests that financial stress and temporal attention may be important therapeutic targets for low-income adults who smoke. A prior randomized controlled trial (RCT) found that an in-person intervention that integrated financial coaching into smoking cessation treatment (“FIERCE”) improved smoking and financial stress outcomes among adults experiencing financial hardship who smoke. However, participants reported time and logistical barriers to attending the in-person sessions. Smartphone app delivery may reduce these barriers, but the feasibility and acceptability of FIERCE delivery via app requires evaluation.
Objective:
This protocol paper reports the methods of an active research study aiming to develop and pilot-test a smartphone app that can enable virtual delivery of the FIERCE intervention.
Methods:
This three-phase study will recruit adults experiencing financial hardship who smoke. During Phase 1, we will conduct three rounds of focus groups (n=5-6/group) to obtain iterative feedback on app designs and prototypes. During Phase 2, we will recruit N=15 participants for an 8-week single-group trial of the app. App engagement data, and participants’ quantitative and qualitative feedback will inform app refinement. During Phase 3, we will conduct a 12-week, two-arm, parallel-group pilot RCT with 50 participants who will be randomized (n=25 per arm) to either: (1) FIERCE app for 12 weeks or (2) startQUIT (a publicly available smoking cessation app from the National Cancer Institute) for 12 weeks. Both groups will receive 8 weeks of mailed nicotine replacement therapy. We will survey participants at 12 weeks to assess their: experiences with the app, self-reported outcomes of smoking behaviors, financial stress, and delay discounting. Self-reported 7-day point prevalence abstinence will be biochemically verified. The study was approved by the NYU Langone Health Institutional Review Board on June 9, 2026.
Results:
National Cancer Institute funding began on June 26, 2026. Phase 1 app development began in July 2026, and focus groups will begin in November 2026. Phase 2 trial recruitment is expected to begin in July 2027. Phase 3 RCT recruitment is expected to begin in June 2028, with all follow-up and data analysis completed by June 2029.
Conclusions:
The proposed smartphone app will leverage the evidence-based components of an in-person smoking cessation program for adults experiencing financial hardship into a potentially more accessible delivery format. Clinical Trial: Not applicable for Phase 1 procedures. Phase 2 and 3 trials will be registered at www.clinicaltrials.gov
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Copyright
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