Mobile Health Technology for Personalized Tobacco Cessation Support among Cancer Survivors in Laos (Project SurvLaos): Protocol for a Pilot Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Tobacco use remains a major cause of preventable deaths and the leading modifiable risk factor for cancer prevention. In Lao People's Democratic Republic (Lao PDR), approximately 60% of male and 15% of female cancer patients smoked cigarettes. Despite, there was no tobacco treatment program for this population. OBJECTIVE This paper describes the design, methods, and analysis plans for our pilot intervention randomized controlled trial (RCT) that is funded by the United States National Cancer Institute and that aims to adapt and evaluate the feasibility and preliminary efficacy of our mHealth intervention to help Lao cancer survivors and their caregivers quit smoking cigarettes. METHODS We utilized an intervention mixed-methods research design, which included a pilot 2-group interventional RCT and an embedded qualitative component to explain RCT outcomes. In the pilot RCT, cancer survivors or caregivers (N=80, no dyads) who smoked were recruited from national hospitals in Vientiane Capital. Recruited participants were randomized to 1 of 2 treatment groups: standard care (SC) or mHealth-based automated treatment (AT). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of nicotine replacement therapy (transdermal patches). AT consists of all SC components plus our fully-automated interactive smartphone-based treatment program, personalized and tailored to cancer survivors or caregivers, and delivered by our Insight app. The primary RCT outcome is biochemically confirmed self-reported 7-day point prevalence abstinence at 3 months post-study enrollment. During the interventional RCT and at the 3-month follow up assessment, we used additional open-ended questions to explore why and how the participants did or did not successfully quit smoking and stay abstinent. RESULTS Data collection occurred from April 2022 to May 2023. Outcome analyses are ongoing. CONCLUSIONS Our study is the first effort that uses scalable and sustainable mHealth technology to provide tobacco cessation treatment to cancer patients/survivors and their caregivers in Lao PDR. This project is built on a strong partnership with stakeholders at national institutions in Lao PDR, which will enhance the intervention’s sustainability in the future. This project and subsequent fully-powered RCT have the potential to improve cancer care and cancer survivorship research in Lao PDR. CLINICALTRIAL ClinicalTrials.gov ID: NCT05253573