Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05253573 |
| Other study ID # |
IRB 14125 |
| Secondary ID |
1R21CA253600-01 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2022 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
University of Oklahoma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 (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.
Description:
Stage 1: Further adapt the AT intervention Before conducting the RCT, the investigators will
use a multi-step process to adapt our already developed AT intervention for use by the target
populations (i.e., cancer survivors and caregivers). These iterative steps include modifying
content, user testing and eliciting feedback, and refining. Specifically, the investigators
will review all communication messages in the current AT program and modify them to ensure
that they are applicable to cancer survivors and caregivers and to both sexes. Then, the
investigators will evaluate the AT content applicability, comprehensibility, and linguistic
simplicity and clarity with ~10 cancer survivors or caregivers. The investigators will ensure
that approximately half of these testing users are women and that the whole testing sample is
demographically diverse. Using input and feedback from these testing users, the investigators
will revise the AT further if needed. These series of tests and user-feedback sessions to
refine the content further and to debug the system will go through an iterative process as
needed. AT content taps on theoretical constructs of the Phase-Based Model (PBM)-a
theoretical framework specific to smoking cessation used in our JITAI.
Stage 2: The pilot RCT Participant recruitment. Research staff will review medical records of
cancer patients receiving care at the 2 hospitals in the past 2 years, screen for their
smoking status documented in the records, and contact those who smoked for further screening.
To recruit caregivers, research staff will contact random cancer patients who did not smoke
and ask if they have a caregiver and if the caregiver smokes. Given the pilot nature of this
study, the investigators propose to recruit independent groups of cancer survivors and
caregivers who smoke, i.e., no dyads of smokers, to avoid potential interpersonal
interactions.
Baseline assessment. Enrolled participants will complete a 45-minute baseline self- or
assisted interview, managed and delivered by REDCap. Participants will be randomly assigned
to SC or AT by the REDCap randomization module (simple, 1:1). Smartphones will be loaned to
participants as needed. All participants will complete a brief training session on smartphone
use and the Insight app. The Insight app also includes a help button for instructions on how
to use each feature, which participants can review at any time.
Treatment groups. 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 the
investigators have translated to and validated in Lao), and a 2-week supply of NRT
(transdermal patches). 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. Adapted from the parent study and based on the PBM, AT content is
designed to increase motivation, self-efficacy, and use of coping skills and reduce nicotine
withdrawal symptoms and stress. AT will begin immediately after enrollment and continue for
12 weeks (about 2 messages/images/videos per day, delivered at participants' preferred time).
Quit date is set at day 14 post-enrollment for AT and SC participants. JITAI content for AT
participants each week will be personalized and tailored to each participant's baseline
information (e.g., sex, cancer types, caregiver status, and current health conditions),
current PBM phase, and responses to the brief weekly EMAs that drive AT (see Measures). Our
AT only targets cigarette smoking because it is the most common type of tobacco used by Lao
smokers (95%).
