Clinical trial NCT05253573: Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
Official title: Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Setthathirath Hospital
name: Lao National Cancer Center
name: National Center for Laboratory and Epidemiology, Lao PDR
name: National Tobacco Control Committee, Lao PDR
name: National Cancer Institute (NCI)
First posted: 2022-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%).

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

Primary outcomes:
measure: Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months
timeFrame: 3 months post enrollment (window for the 3-month follow-up assessment: weeks 10-14).
measure: Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months in Each Cancer Survivor/Caregiver Subgroup.
timeFrame: 3 months post-enrollment (window for the 3-month follow-up assessment: weeks 10-14)
Secondary outcomes:
measure: Cigarettes Smoked Per Day at 3-month Follow-up (Quit=0) Among All Participants
timeFrame: In-clinic 3-month follow-up assessments (window: weeks 10-14)
measure: Cigarettes Smoked Per Day at 3-month Follow-up Among Participants Who Smoked at 3 Months
timeFrame: In-clinic 3-month follow-up assessments (window: weeks 10-14)
measure: Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup (Quit=0), Among 'All' Participants
timeFrame: In-clinic 3-month follow-up assessments (window: weeks 10-14)
measure: Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup, Among Participants Who Smoked at 3 Months
timeFrame: In-clinic 3-month follow-up assessments (window: weeks 10-14)
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: Lao National Cancer Center
city: Vientiane
country: Lao People's Democratic Republic
facility: Setthathirath Hospital
Study officials:
affiliation: Stephenson Cancer Center, University of Oklahoma Health Sciences Center (OUHSC)
name: Thanh C Bui
role: PRINCIPAL_INVESTIGATOR
References: