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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 1

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Behavioral: Smoking Cessation Intervention (New website); Behavioral: Health Education; Behavioral: Smoking Cessation Intervention (Standard of care website); Other: Health Promotion and Education; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04502524

R21CA236980 (U.S. NIH Grant/Contract)

NCI-2020-05587 (Registry Identifier)

10097 (Registry Identifier)

RG1007109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Health Education

Behavioral: Smoking Cessation Intervention (New website)

Other: Health Promotion and Education

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

Active Comparator group

Description:

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.

Treatment:

Behavioral: Smoking Cessation Intervention (Standard of care website)

Other: Questionnaire Administration

Behavioral: Health Education

Other: Health Promotion and Education