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

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention (New website); Behavioral: Health Education; Other: Health Promotion and Education; Behavioral: Smoking Cessation Intervention (Standard of care website)

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Bedford VA Research Corporation, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention (New website); Complete the new website smoking cessation program; Other Names: Smoking and Tobacco Use Cessation Interventions; Behavioral: 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
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: 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; Behavioral: Smoking Cessation Intervention (Standard of care website); Complete the standard of care website smoking cessation intervention; Other Names: standard of care; standard therapy; best practice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RG1007109; 10097 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2020-05587 (Registry Identifier: NCI / CTRP); R21CA236980 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No