Clinical trial NCT04502524: Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans
Official title: A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction With Assigned Treatment
timeFrame: At 3 months post-randomization
measure: Number of Server-recorded Logins to Assigned Website
timeFrame: At 3 months
measure: Duration of Website Use (Days Since First Login)
timeFrame: At 3 months
Secondary outcomes:
measure: Number of Quit Attempts
timeFrame: At 3 months
measure: Cotinine-confirmed, Self-reported Abstinence From Smoking
timeFrame: In the 7 days prior to the 3-month follow up
measure: Cotinine-confirmed, Self-reported Abstinence From Smoking
timeFrame: In the 30 days prior to the 3-month follow up
measure: Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)
timeFrame: In the 7 days prior to the 3-month follow up
measure: Change in Readiness to Quit
timeFrame: Baseline up to 3-month follow-up
measure: Change in Acceptance of Smoking Triggers
timeFrame: Baseline up to 3-month follow-up
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Bedford VA Research Corporation, Inc.
state: Massachusetts
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jaimee Heffner
role: PRINCIPAL_INVESTIGATOR
References: