Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALSmoking Cessation Intervention (New website)
Complete the new website smoking cessation program
BEHAVIORALSmoking Cessation Intervention (Standard of care website)
Complete the standard of care website smoking cessation intervention
BEHAVIORALHealth Education
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.
OTHERHealth Promotion and Education
Receive motivational and reminder text messages
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Assigned Treatment | At 3 months post-randomization | 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. |
| Number of Server-recorded Logins to Assigned Website | At 3 months | 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. |
| Duration of Website Use (Days Since First Login) | At 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Readiness to Quit | Baseline up to 3-month follow-up | 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. |
| Number of Quit Attempts | At 3 months | 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. |
| Change in Acceptance of Smoking Triggers | Baseline up to 3-month follow-up | 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. |
| Cotinine-confirmed, Self-reported Abstinence From Smoking | In the 7 days prior to the 3-month follow up | 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. |
| Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy) | In the 7 days prior to the 3-month follow up | 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. |
Countries
United States
Participant flow
Recruitment details
Fifty-three participants were eligible and enrolled in the study. The final sample comprised 49 participants who were randomized between February 3, 2021 and October 22, 2021.
Pre-assignment details
Four participants who were enrolled in the study were not randomized because they were lost to follow-up (n=3) or they withdrew (n=1) prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (New Website Program, Handout, Text Message) 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.
Smoking Cessation Intervention (New website): Complete the new website smoking cessation program
Health Education: 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.
Health Promotion and Education: Receive motivational and reminder text messages
Questionnaire Administration: Ancillary studies | 25 |
| Arm II (Standard Care VA Website, Handout, Text Message) 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.
Smoking Cessation Intervention (Standard of care website): Complete the standard of care website smoking cessation intervention
Health Education: 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.
Health Promotion and Education: Receive motivational and reminder text messages
Questionnaire Administration: Ancillary studies | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Arm I (New Website Program, Handout, Text Message) | Arm II (Standard Care VA Website, Handout, Text Message) | Total |
|---|---|---|---|
| Age, Continuous | 47.9 years | 54.8 years | 51.3 years |
| Contemplation Ladder | 8.0 units on a scale STANDARD_DEVIATION 2.3 | 7.8 units on a scale STANDARD_DEVIATION 2.1 | 7.9 units on a scale STANDARD_DEVIATION 2.2 |
| Fagerström Test for Nicotine Dependence (FTND) | 4.3 units on a scale | 4.2 units on a scale | 4.3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 20 Participants | 39 Participants |
| Region of Enrollment United States | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
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.
Time frame: At 3 months
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Duration of Website Use (Days Since First Login) | 18.7 Days since first login | Standard Deviation 27.3 |
| Arm II (Standard Care VA Website, Handout, Text Message) | Duration of Website Use (Days Since First Login) | 26.7 Days since first login | Standard Deviation 47.2 |
p-value: 0.45195% CI: [-1.6, 0.71]Regression, negative binomial
Primary
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.
Time frame: At 3 months
Population: All survey respondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Number of Server-recorded Logins to Assigned Website | 3.7 Count of number of times logged in | Standard Deviation 3.6 |
| Arm II (Standard Care VA Website, Handout, Text Message) | Number of Server-recorded Logins to Assigned Website | 3.2 Count of number of times logged in | Standard Deviation 4.1 |
p-value: 0.85295% CI: [-0.46, 0.56]Regression, negative binomial
Primary
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.
Time frame: At 3 months post-randomization
Population: All survey respondents
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Satisfaction With Assigned Treatment | Not At All/A Little | 0 Participants |
| Arm I (New Website Program, Handout, Text Message) | Satisfaction With Assigned Treatment | Somewhat/Mostly/Very Much | 17 Participants |
| Arm II (Standard Care VA Website, Handout, Text Message) | Satisfaction With Assigned Treatment | Not At All/A Little | 1 Participants |
| Arm II (Standard Care VA Website, Handout, Text Message) | Satisfaction With Assigned Treatment | Somewhat/Mostly/Very Much | 18 Participants |
Comparison: For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.p-value: 0.999Fisher Exact
Secondary
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.
Time frame: Baseline up to 3-month follow-up
Population: All survey respondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Change in Acceptance of Smoking Triggers | 0.4 score on a scale | Standard Deviation 0.6 |
| Arm II (Standard Care VA Website, Handout, Text Message) | Change in Acceptance of Smoking Triggers | 0.3 score on a scale | Standard Deviation 0.8 |
p-value: 0.6795% CI: [-0.4, 0.61]Regression, Linear
Secondary
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.
Time frame: Baseline up to 3-month follow-up
Population: All survey respondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Change in Readiness to Quit | -0.4 score on a scale | Standard Deviation 3.3 |
| Arm II (Standard Care VA Website, Handout, Text Message) | Change in Readiness to Quit | -0.5 score on a scale | Standard Deviation 3.6 |
p-value: 0.50495% CI: [-1.13, 2.26]Regression, Linear
Secondary
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.
Time frame: In the 30 days prior to the 3-month follow up
Population: All survey respondents.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Cotinine-confirmed, Self-reported Abstinence From Smoking | 3 participants |
| Arm II (Standard Care VA Website, Handout, Text Message) | Cotinine-confirmed, Self-reported Abstinence From Smoking | 3 participants |
p-value: 0.94195% CI: [0.17, 5.29]Regression, Logistic
Secondary
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.
Time frame: In the 7 days prior to the 3-month follow up
Population: All survey respondents.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Cotinine-confirmed, Self-reported Abstinence From Smoking | 3 Participants |
| Arm II (Standard Care VA Website, Handout, Text Message) | Cotinine-confirmed, Self-reported Abstinence From Smoking | 4 Participants |
p-value: 0.60295% CI: [0.13, 3.32]Regression, Logistic
Secondary
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.
Time frame: At 3 months
Population: All survey respondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Number of Quit Attempts | 1.7 Number of quit attempts | Standard Deviation 1.1 |
| Arm II (Standard Care VA Website, Handout, Text Message) | Number of Quit Attempts | 3.2 Number of quit attempts | Standard Deviation 6.7 |
p-value: 0.50895% CI: [-1.46, 0.003]Regression, negative binomial
Secondary
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.
Time frame: In the 7 days prior to the 3-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (New Website Program, Handout, Text Message) | Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy) | 2 participants |
| Arm II (Standard Care VA Website, Handout, Text Message) | Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy) | 3 participants |
p-value: 0.61295% CI: [0.09, 4.12]Regression, Logistic