Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults

M.D. Anderson Cancer Center

Status: Completed

Conditions: Cigarette Smoking; Current Smoker

Treatments: Other: Educational Intervention; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04009590

2018-0186 (Other Identifier)

NCI-2018-03518 (Registry Identifier)

R42DA035012 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This trial studies how well Quit4Health intervention works in supporting smoking cessation and preventing smoking initiation in young adults. Quit4Health intervention may help young adults learn more about the risks of tobacco use and may help them to quit smoking.

Full description

PRIMARY OBJECTIVES:

I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and remain tobacco-free at 6 months than subjects randomized to the education only control group.

II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the education only control group.

SECONDARY OBJECTIVES:

I. To evaluate whether well-established predictors of susceptibility and barriers to cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs, attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of tobacco use.

II. To evaluate whether, at the end-of-treatment (EOT) assessment, participants (both smokers and non-smokers) in Quit4Health will report a significantly better perception of Quit4Health (message relevance, tailoring to specific needs based on tobacco use status, motivation to quit, etc.) compared with their counterparts in the education only control arm.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.

GROUP II: Participants read an educational booklet about cigarettes and other tobacco products for 1 month.

After completion of study, participants are followed at 3 and 6 months.

Enrollment: 579 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be enrolled in at least one class at Houston Community College (HCC) Central campus, West Loop campus or Spring Branch campus (cessation and prevention/advocacy groups)
• Speak and read English (cessation and prevention/advocacy groups)
• Own an Android or iOS smartphone (cessation and prevention/advocacy groups)
• Provide current and relevant contact information (cessation and prevention/advocacy groups)
• Smoked at least one cigarette (or more) in the past 30 days (cessation group)
• Have data and wifi capabilities on their mobile device (cessation and prevention/advocacy groups)
• Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (prevention/advocacy groups)

Exclusion criteria

• People who score 16 or above on the Center for Epidemiologic Studies Depression (CESD) thus showing evidence of major depressive disorder (cessation and prevention/advocacy groups)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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579 participants in 2 patient groups

GROUP I (Quit4Health)

Experimental group

Description:

Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.

Treatment:

Other: Questionnaire Administration

Behavioral: Smoking Cessation Intervention

Group II (educational booklet)

Active Comparator group

Description:

Participants read an educational booklet about cigarettes and other tobacco products for 1 month.

Treatment:

Other: Questionnaire Administration

Other: Educational Intervention