Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans

Study Overview
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Brief Summary
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This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to quit smoking. The study will compare the new website smoking cessation program to the current standard care website smoking cessation program offered by the Veterans Administration (VA). Both website interventions will be accompanied by a text messaging program that includes: (1) motivational messages, and (2) reminders to use the assigned program. Both of the website interventions can help smokers quit or cut back on how much they smoke, thus dramatically reducing their chances of developing tobacco-related health conditions.

Detailed Description
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OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use the new website smoking cessation program, which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with handouts and available resources provided by the VA for continued support for smoking cessation. ARM II: Participants use the VA standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation. After study randomization, participants are followed up at 1 and 3 months.

Official Title
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A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Behavioral: Smoking Cessation Intervention (New website)
* Behavioral: Smoking Cessation Intervention (Standard of care website)
* Behavioral: Health Education
* Other: Health Promotion and Education
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be a US veteran Participants must be low-income, as defined by falling below Veterans Health Administration (VHA) national income threshold for no-cost healthcare Participants must be a current smoker, averaging at least 5 cigarettes/day for the last 30 days Participants must have weekly internet access for the next 3 months Participants must self-report current use of a personal email address to receive the link to their assigned web site Participants must self-report being willing to complete all study activities Participants must be willing to receive study-related text messages Exclusion Criteria: Currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric hospitalization Previous participation in the treatment development stage of the new smoking cessation website program Prior use of the SmokefreeVET web site Member of the same household as another research participant Woman who is pregnant or breastfeeding, or planning to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (New website program, handout, text message)<br>Participants complete the new website smoking cessation program which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants will also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with all session handouts and available resources provided by the VA for continued support for smoking cessation. | Behavioral: Smoking Cessation Intervention (New website)<br>* Complete the new website smoking cessation program<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Behavioral: Health Education<br>* Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.<br>Other: Health Promotion and Education<br>* Receive motivational and reminder text messages<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (Standard care VA website, handout, text message)<br>Participants use the standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation. | Behavioral: Smoking Cessation Intervention (Standard of care website)<br>* Complete the standard of care website smoking cessation intervention<br>* Other names: best practice;Behavioral: Health Education<br>* Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.<br>Other: Health Promotion and Education<br>* Receive motivational and reminder text messages<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Assigned Treatment | Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all satisfied to very satisfied. Will dichotomize values at a threshold of somewhat satisfied or higher. We tested for differences between arms using a Fisher's Exact test. | At 3 months post-randomization | 
| Number of Server-recorded Logins to Assigned Website | Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for. | At 3 months | 
| Duration of Website Use (Days Since First Login) | Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for. | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Quit Attempts | Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for. | At 3 months | 
| Cotinine-confirmed, Self-reported Abstinence From Smoking | Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers. | In the 7 days prior to the 3-month follow up | 
| Cotinine-confirmed, Self-reported Abstinence From Smoking | Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers. | In the 30 days prior to the 3-month follow up | 
| Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy) | Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers. | In the 7 days prior to the 3-month follow up | 
| Change in Readiness to Quit | Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. | Baseline up to 3-month follow-up | 
| Change in Acceptance of Smoking Triggers | Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change. | Baseline up to 3-month follow-up |