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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2022-01-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Smoking Cessation Intervention (New website)

Intervention Type BEHAVIORAL

Complete the new website smoking cessation program

Health Education

Intervention Type 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.

Health Promotion and Education

Intervention Type OTHER

Receive motivational and reminder text messages

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Smoking Cessation Intervention (Standard of care website)

Intervention Type BEHAVIORAL

Complete the standard of care website smoking cessation intervention

Health Education

Intervention Type 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.

Health Promotion and Education

Intervention Type OTHER

Receive motivational and reminder text messages

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Smoking Cessation Intervention (New website)

Complete the new website smoking cessation program

Intervention Type BEHAVIORAL

Smoking Cessation Intervention (Standard of care website)

Complete the standard of care website smoking cessation intervention

Intervention Type 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.

Intervention Type BEHAVIORAL

Health Promotion and Education

Receive motivational and reminder text messages

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Smoking and Tobacco Use Cessation Interventions standard of care standard therapy best practice

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes