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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502524
• Other study ID #: RG1007109
• Secondary ID: NCI-2020-05587R2
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: March 2023
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Smoking Cessation Intervention (New website)
Complete the new website smoking cessation program
• 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.

Other:
• Health Promotion and Education
Receive motivational and reminder text messages
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Bedford VA Research Corporation, Inc.	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At 3 months post-randomization
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.	At 3 months
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.	At 3 months
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.	At 3 months
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.	In the 7 days prior to the 3-month follow up
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.	In the 30 days prior to the 3-month follow up
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.	In the 7 days prior to the 3-month follow up
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.	Baseline up to 3-month follow-up
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.	Baseline up to 3-month follow-up