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

NCT05253573 | Completed Phase 2 Results

• 2 other identifiers: IRB 141253R21CA253600-02S1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months

  The primary outcome was smoking status at 3 months post-enrollment. Abstinence was defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO \<6 ppm. The percentage of participants in each treatment group achieving biochemically verified 7-day point prevalence abstinence at 3 months is reported.

  3 months post enrollment (window for the 3-month follow-up assessment: weeks 10-14).

• Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months in Each Cancer Survivor/Caregiver Subgroup.

  The primary outcome was smoking status at 3 months post-enrollment. Abstinence was defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO \<6 ppm. The percentage of cancer survivor/caregiver participants in each treatment group, achieving biochemically verified 7-day point prevalence abstinence at 3 months is reported.

  3 months post-enrollment (window for the 3-month follow-up assessment: weeks 10-14)

Secondary Outcomes (4)

• Cigarettes Smoked Per Day at 3-month Follow-up (Quit=0) Among All Participants

  In-clinic 3-month follow-up assessments (window: weeks 10-14)

• Cigarettes Smoked Per Day at 3-month Follow-up Among Participants Who Smoked at 3 Months

  In-clinic 3-month follow-up assessments (window: weeks 10-14)

• Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup (Quit=0), Among 'All' Participants

  In-clinic 3-month follow-up assessments (window: weeks 10-14)

• Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup, Among Participants Who Smoked at 3 Months

  In-clinic 3-month follow-up assessments (window: weeks 10-14)

Study Arms (2)

Automated Treatment

EXPERIMENTAL

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; Behavioral: Self-help materials (to support smoking cessation); Behavioral: Smartphone-based automated treatment for smoking cessation

Standard Care

ACTIVE COMPARATOR

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; Behavioral: Self-help materials (to support smoking cessation)

Interventions

Nicotine patch DRUG

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.

Automated Treatment; Standard Care

Self-help materials (to support smoking cessation) BEHAVIORAL

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.

Automated Treatment; Standard Care

Smartphone-based automated treatment for smoking cessation BEHAVIORAL

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.

Automated Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Setthathirath Hospital: collaborator
• Lao National Cancer Center: collaborator
• National Center for Laboratory and Epidemiology, Lao PDR: collaborator
• National Tobacco Control Committee, Lao PDR: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Lao National Cancer Center

Vientiane, Laos

Location

Setthathirath Hospital

Vientiane, Laos

Location

Related Publications (1)

• Keopaseuth 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 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Thanh Cong Bui, MD, DrPH
• Organization: University of Oklahoma Stephenson Cancer Center

thanh-c-bui@ouhsc.edu

1-405-271-8001

Study Officials

• Thanh C Bui

  Stephenson Cancer Center, University of Oklahoma Health Sciences Center (OUHSC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 24, 2022
• Study Start: April 20, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After RCT data collection is complete.
• 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.

Locations

LA (2)