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

NCT04502524 | Completed Phase 1 Results

• 4 other identifiers: RG1007109NCI-2020-05587R21CA23698010097
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Number of Quit Attempts

  At 3 months

• Cotinine-confirmed, Self-reported Abstinence From Smoking

  In the 7 days prior to the 3-month follow up

• Cotinine-confirmed, Self-reported Abstinence From Smoking

  In the 30 days prior to the 3-month follow up

• Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)

  In the 7 days prior to the 3-month follow up

• Change in Readiness to Quit

  Baseline up to 3-month follow-up

Study Arms (2)

Arm I (New website program, handout, text message)

EXPERIMENTAL

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); Behavioral: Health Education; Other: Health Promotion and Education; Other: Questionnaire Administration

Arm II (Standard care VA website, handout, text message)

ACTIVE COMPARATOR

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); Behavioral: Health Education; Other: Health Promotion and Education; Other: Questionnaire Administration

Interventions

Smoking Cessation Intervention (New website) BEHAVIORAL

Complete the new website smoking cessation program

Also known as: Smoking and Tobacco Use Cessation Interventions

Arm I (New website program, handout, text message)

Smoking Cessation Intervention (Standard of care website) BEHAVIORAL

Complete the standard of care website smoking cessation intervention

Also known as: standard of care, standard therapy, best practice

Arm II (Standard care VA website, handout, text message)

Health Education BEHAVIORAL

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.

Arm I (New website program, handout, text message); Arm II (Standard care VA website, handout, text message)

Health Promotion and Education OTHER

Receive motivational and reminder text messages

Arm I (New website program, handout, text message); Arm II (Standard care VA website, handout, text message)

Questionnaire Administration OTHER

Ancillary studies

Arm I (New website program, handout, text message); Arm II (Standard care VA website, handout, text message)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Bedford VA Research Corporation, Inc.

Bedford, Massachusetts, 01730, United States

Location

Related Publications (1)

• Heffner JL, Kelly MM, Reilly ED, Reece SG, Claudio T, Serfozo E, Baker K, Watson NL, Karekla M. An Avatar-Led Web-Based and SMS Text Message Smoking Cessation Program for Socioeconomically Disadvantaged Veterans: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Apr 14;7:e44503. doi: 10.2196/44503.

  PMID: 37058346 DERIVED

MeSH Terms

Interventions

Smoking Devices; Standard of Care; Practice Guidelines as Topic; Health Promotion; Educational Status

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Guidelines as Topic; Quality Assurance, Health Care; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Limitations and Caveats

The goal was to establish feasibility rather than to detect statistically significant differences between arms. The sample size was small, and follow-ups were limited to short-term outcomes. Some ACT interventions have demonstrated greater effects when evaluated at long-term follow-up. This study was conducted during the COVID-19 pandemic, which represents a unique context. The study design was also impacted by the pandemic, transforming a primarily in-person design to a fully remote one.

Results Point of Contact

• Title: Jaimee Heffner, Ph.D., Associate Professor
• Organization: Fred Hutchinson Cancer Center

jheffner@fredhutch.org

206.667.7314

Study Officials

• Jaimee Heffner

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 6, 2020
• Study Start: February 3, 2021
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)