Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
Status:
Not yet recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
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 projectis 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 (n=40) and
caregivers (n=40) 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 (20 cancer survivors and 20 caregivers in each group). 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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Oklahoma
Collaborators:
National Cancer Center, Lao PDR National Center for Laboratory and Epidemiology, Lao PDR National Tobacco Control Committee, Lao PDR Setthathirath Hospital, Lao PDR