Trial Outcomes & Findings for Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos (NCT NCT05253573)
NCT ID: NCT05253573
Last Updated: 2024-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
3 months post enrollment (window for the 3-month follow-up assessment: weeks 10-14).
Results posted on
2024-08-28
Participant Flow
A total number of 80 participants, cancer survivors and independent caregivers, who smoke were recruited and randomized to treatment. All enrolled caregivers were independent from enrolled cancer patients/survivors (i.e.. no dyads). Therefore, each enrolled participant was unique.
Participant milestones
| Measure |
Automated Treatment (AT)
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
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).
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Cancer Patients/Survivors
|
15
|
15
|
|
Overall Study
Caregivers
|
25
|
25
|
|
Overall Study
Completed Cancer Patients/Survivors
|
14
|
15
|
|
Overall Study
Completed Caregivers
|
25
|
25
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Automated Treatment (AT)
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
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).
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.
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
Baseline characteristics by cohort
| Measure |
Automated Treatment
n=39 Participants
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.
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. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care. we will provide NRT to all participants in both groups in the early cessation phase.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: automated treatment(AT) includes text messages, images, and videos. The AT content is designed to tap the theoretical mechanisms described in the Phase-Based Model. 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. AT will begin immediately after enrollment and continue for 12 weeks. 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.
|
Standard Care
n=40 Participants
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).
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.
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.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.74 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
45.47 years
STANDARD_DEVIATION 9.71 • n=7 Participants
|
44.62 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
|
Sex/Gender, Customized
According to Group · Cancer Patients/Survivor Participants - Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex/Gender, Customized
According to Group · Caregiver Participants - Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
According to Group · Cancer Patients/Survivor Participants - Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex/Gender, Customized
According to Group · Caregiver Participants - Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Laos · Urban
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Laos · Non-Urban/Town
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (Asia)
Lao
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (Asia)
Khmou
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post enrollment (window for the 3-month follow-up assessment: weeks 10-14).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.
Outcome measures
| Measure |
Automated Treatment
n=39 Participants
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.
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. 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.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: The automated treatment (AT) includes 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 12 weeks. 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.
|
Standard Care
n=40 Participants
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).
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.
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.
|
Automated Treatment (AT) - Caregiver Participants
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
Standard Care - Caregiver Participants
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).
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.
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.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months
Smoking at 3 Months
|
10 Participants
|
24 Participants
|
—
|
—
|
|
Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months
Abstinent at 3 Months
|
29 Participants
|
16 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 months post-enrollment (window for the 3-month follow-up assessment: weeks 10-14)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.
Outcome measures
| Measure |
Automated Treatment
n=14 Participants
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.
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. 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.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: The automated treatment (AT) includes 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 12 weeks. 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.
|
Standard Care
n=15 Participants
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).
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.
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.
|
Automated Treatment (AT) - Caregiver Participants
n=25 Participants
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
Standard Care - Caregiver Participants
n=25 Participants
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).
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.
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.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months in Each Cancer Survivor/Caregiver Subgroup.
Smoking at 3 Months
|
2 Participants
|
5 Participants
|
8 Participants
|
19 Participants
|
|
Percentage of Participants Achieving Biochemically Verified 7-day Point Prevalence Abstinence at 3 Months in Each Cancer Survivor/Caregiver Subgroup.
Abstinent at 3 Months
|
12 Participants
|
10 Participants
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: In-clinic 3-month follow-up assessments (window: weeks 10-14)Population: The overall number of participants analyzed in this outcome measure reflects the combined number of cancer survivor and independent caregiver participants.
At the 3-month follow-up, participants self-reported their average current number of cigarettes smoked per day. For those who quit, the number of cigarettes smoked per day was 0.
Outcome measures
| Measure |
Automated Treatment
n=39 Participants
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.
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. 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.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: The automated treatment (AT) includes 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 12 weeks. 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.
|
Standard Care
n=40 Participants
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).
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.
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.
|
Automated Treatment (AT) - Caregiver Participants
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
Standard Care - Caregiver Participants
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).
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.
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.
|
|---|---|---|---|---|
|
Cigarettes Smoked Per Day at 3-month Follow-up (Quit=0) Among All Participants
|
3.64 Number of cigarettes smoked per day
Standard Deviation 6.20
|
6.6 Number of cigarettes smoked per day
Standard Deviation 6.20
|
—
|
—
|
SECONDARY outcome
Timeframe: In-clinic 3-month follow-up assessments (window: weeks 10-14)At the 3-month follow-up, participants self-reported their average current number of cigarettes smoked per day. This analysis excludes those who quit.
Outcome measures
| Measure |
Automated Treatment
n=10 Participants
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.
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. 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.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: The automated treatment (AT) includes 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 12 weeks. 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.
|
Standard Care
n=24 Participants
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).
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.
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.
|
Automated Treatment (AT) - Caregiver Participants
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
Standard Care - Caregiver Participants
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).
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.
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.
|
|---|---|---|---|---|
|
Cigarettes Smoked Per Day at 3-month Follow-up Among Participants Who Smoked at 3 Months
|
4 Number of cigarettes smoked per day
Standard Deviation 3.60
|
11.05 Number of cigarettes smoked per day
Standard Deviation 5.27
|
—
|
—
|
SECONDARY outcome
Timeframe: In-clinic 3-month follow-up assessments (window: weeks 10-14)At the 3-month follow-up, participants self-reported their average current number of cigarettes smoked per day. For those who quit, the number of cigarettes smoked per day was 0. This analysis includes all participants in each treatment group.
Outcome measures
| Measure |
Automated Treatment
n=14 Participants
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.
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. 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.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: The automated treatment (AT) includes 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 12 weeks. 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.
|
Standard Care
n=15 Participants
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).
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.
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.
|
Automated Treatment (AT) - Caregiver Participants
n=25 Participants
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
Standard Care - Caregiver Participants
n=25 Participants
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).
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.
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.
|
|---|---|---|---|---|
|
Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup (Quit=0), Among 'All' Participants
|
2.85 Number of cigarettes smoked per day
Standard Deviation 5.70
|
2.40 Number of cigarettes smoked per day
Standard Deviation 4.30
|
4.08 Number of cigarettes smoked per day
Standard Deviation 6.53
|
9.12 Number of cigarettes smoked per day
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: In-clinic 3-month follow-up assessments (window: weeks 10-14)Population: All cancer patients/survivor participants in the Standard Care treatment group quit smoking at 3 months.
At the 3-month follow-up, participants self-reported their average current number of cigarettes smoked per day. This analysis includes only participants in each treatment group who smoked at 3 months. All cancer patients/survivor participants in the Standard Care treatment group self-reported quit smoking at 3 months.
Outcome measures
| Measure |
Automated Treatment
n=1 Participants
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.
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. 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.
Self-help materials: 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.
Smartphone-based automated treatment for smoking cessation: The automated treatment (AT) includes 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 12 weeks. 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.
|
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).
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.
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.
|
Automated Treatment (AT) - Caregiver Participants
n=2 Participants
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.
Nicotine patch: The provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care.
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.
Smartphone-based automated treatment for smoking cessation: Automated treatment(AT) includes 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 12 weeks. 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.
|
Standard Care - Caregiver Participants
n=19 Participants
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).
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.
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.
|
|---|---|---|---|---|
|
Cigarettes Smoked Per Day at 3-month Follow-up in Each Cancer Survivor/Caregiver Subgroup, Among Participants Who Smoked at 3 Months
|
5 Number of cigarettes smoked per day
Standard Deviation 0
|
—
|
3.50 Number of cigarettes smoked per day
Standard Deviation 4.94
|
11.05 Number of cigarettes smoked per day
Standard Deviation 5.27
|
Adverse Events
Automated Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thanh Cong Bui, MD, DrPH
University of Oklahoma Stephenson Cancer Center
Phone: 1-405-271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place