Clinical trial · Interventional
Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The parent project (1R21CA253600-01, R21 phase: 9/1/2020-8/31/2022, R33 phase: 9/1/2022-8/31/2025) aims to adapt and evaluate the efficacy of our theoretically and empirically based mobile health (mHealth) technology to help general patients in Lao People's Democratic Republic (Lao PDR) quit smoking cigarettes. This mHealth automated treatment (AT) approach includes a fully automated, interactive, personalized, smartphone-based intervention for behavioral treatment, delivered through our Insight platform. The purpose of this projects to expand our mHealth-based intervention to address the pressing need for smoking cessation among cancer survivors and their caregivers in Lao PDR. In this project, the investigators will further adapt the AT intervention to ensure that its content is comprehensible and relevant to the target populations (i.e., cancer survivors and caregivers). Then, the investigators will conduct a pilot randomized controlled trial (RCT, N=80) to evaluate the preliminary efficacy of the intervention. Cancer survivors and caregivers of both sexes who smoke will be identified via medical records at the Setthathirath Hospital (SH) and Lao National Cancer Center (LNCC) and recruited. Similar to the parent project's design, participants will be randomized to 1 of 2 treatment groups: standard care (SC) or AT. SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of nicotine patches. AT consists of all SC components plus our fully-automated interactive smartphone-based treatment program, personalized and tailored to cancer survivors or caregivers. The primary RCT outcome is biochemically confirmed self-reported 7-day point prevalence abstinence at 3 months post-study enrollment. The specific aims are as follows: Aim 1: Evaluate the feasibility of AT in cancer survivors and caregivers. Hypothesis (H1): ≥75% of AT content will be viewed/opened as indicated by digital date/time stamp in Insight. Aim 2: Evaluate the preliminary efficacy of AT in each cancer survivor/caregiver subgroup. Hypothesis (H2): At the 12-week follow-up, 7-day point prevalence abstinence will be higher in the AT (vs. SC) group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cigarette Smoking | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nicotine patch | Drug | — | UNRESOLVED |
| Self-help materials (to support smoking cessation) | Behavioral | — | UNRESOLVED |
| Smartphone-based automated treatment for smoking cessation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Automated Treatment
- description
- AT consists of all SC components plus a fully automated smartphone-based JITAI that involves proactive, interactive, and personalized messages, images, or videos in Lao.
- interventionNames
- Drug: Nicotine patch
- Behavioral: Self-help materials (to support smoking cessation)
- Behavioral: Smartphone-based automated treatment for smoking cessation
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- SC consists of brief advice to quit smoking delivered by research staff, self-help written materials (the WHO's "A guide for tobacco users to quit" that we have translated to and validated in Lao), and a 2-week supply of NRT (transdermal patches).
- interventionNames
- Drug: Nicotine patch
- Behavioral: Self-help materials (to support smoking cessation)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 years * Self-reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and currently smoke ≥1 cigarette/day) * Willing to set a quit date within 2 weeks of study enrollment * Able to provide written informed consent to participate * Able to read Lao (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form). Exclusion Criteria: * History of a medical condition that precludes use of NRT * Ineligibility to participate based on medical or psychiatric conditions diagnosed by a physician/clinician * Enrollment in another cessation program or current use of other cessation medications
References
Publications (1)
- DERIVEDKeopaseuth P, Xangsayarath P, Kulkarni S, Phandouangsy K, Soulaphy C, Alounlungsy P, Dittaphong V, Xayavong D, Vongdala C, Siengsounthone L, Businelle M, Frank-Pearce SG, Vidrine DJ, Vidrine JI, Bui TC. Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors and Caregivers in Laos (Project SurvLaos): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 30;14:e66517. doi: 10.2196/66517. PMID 40736921