Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos (SurvLaos)

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Drug: Nicotine patch; Behavioral: Self-help materials (to support smoking cessation); Behavioral: Smartphone-based automated treatment for smoking cessation

Detailed 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%).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Lao People's Democratic Republic
  • Vientiane, Lao People's Democratic Republic
    • Setthathirath Hospital
  • Vientiane, Lao People's Democratic Republic
    • Lao National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated Treatment; 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.	Drug: Nicotine patch; Provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. Evidence supporting the safety and efficacy of NRT is vast. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care. Therefore, we will provide NRT to all participants in both groups in the early cessation phase.; Behavioral: Self-help materials (to support smoking cessation); Our team has translated and validated the World Health Organization's "A guide for tobacco users to quit" into Lao language for use as the self-help material in this study.; Behavioral: Smartphone-based automated treatment for smoking cessation; The automated treatment(AT) include text messages, images, and videos. The AT content is designed to tap the theoretical mechanisms described in the Phase-Based Model (PBM). That is, treatment content is designed to increase motivation, self-efficacy, use of coping skills, and social support, while reducing nicotine withdrawal symptoms and stress. The AT will begin immediately after enrollment and continue for a 12-week period. The AT approach allows for several levels of personalization for each participant, including tailoring to participants' specific health conditions, individual cessation phases, and participants' self-efficacy level or smoking status in the past week.
Active Comparator: Standard Care; 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).	Drug: Nicotine patch; Provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. Evidence supporting the safety and efficacy of NRT is vast. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care. Therefore, we will provide NRT to all participants in both groups in the early cessation phase.; Behavioral: Self-help materials (to support smoking cessation); Our team has translated and validated the World Health Organization's "A guide for tobacco users to quit" into Lao language for use as the self-help material in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking status at 3 months post-enrollment	The primary outcome is smoking status at 3 months post-enrollment. Abstinence will be defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO <6 ppm.	3 months post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly self-reported smoking status	Participants will be asked to self-report their smoking status (yes/no) in the past week when completing the brief weekly smartphone assessments over a 3-month period, delivered via the Insight-app.	Weekly during the 3-month treatment period
Numbers of cigarette smoked per day at 3-month follow-up	At the 3-month follow-up, participants will self-report their average current numbers of cigarettes smoked per day.	In-clinic assessments at months 3

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Cancer Institute (NCI); Setthathirath Hospital, Lao PDR; National Cancer Center, Lao PDR; National Center for Laboratory and Epidemiology, Lao PDR; National Tobacco Control Committee, Lao PDR
• Investigators: Principal Investigator: Thanh C Bui, Stephenson Cancer Center, University of Oklahoma Health Sciences Center (OUHSC)

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IRB 14125; 1R21CA253600-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified IPD will be shared upon request, with an established data sharing and using agreement.
• IPD Sharing Time Frame: After RCT data collection is complete.
• IPD Sharing Access Criteria: The PI and OUHSC will review data sharing requests. An inter-institutional data sharing and using agreement will be established. Then, deidentified data will be shared via an institutionally-approved secure mechanism.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes