Phase 2
Completed N=80
Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
Cigarette Smoking
Source: ClinicalTrials.gov NCT05253573 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months — 10; 24; 29; 16 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months |
10; 24; 29; 16 | — |
| PRIMARY Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months in Each Cancer Survivor/Caregiver Subgroup. |
2; 5; 8; 19; 12; 10 | — |
| SECONDARY Cigarettes Smoked Per Day at 3-month Follow-up (Quit=0) Among All Participants |
3.64; 6.6 | — |
| SECONDARY Cigarettes Smoked Per Day at 3-month Follow-up Among Participants Who Smoked at 3 Months |
4; 11.05 | — |
| SECONDARY Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup (Quit=0), Among 'All' Participants |
2.85; 2.40; 4.08; 9.12 | — |
| SECONDARY Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup, Among Participants Who Smoked at 3 Months |
5; 3.50; 11.05 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05253573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.