Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Lung Cancer; Smoking; Tobacco Use

Treatments: Behavioral: Florida Tobacco Quitline; Behavioral: Telephone counseling sessions; Behavioral: Access to a web-based video; Drug: Nicotine patch and lozenges

Study type: Interventional

Funder types: Other

Identifiers

NCT05362318

MCC-21108

Details and patient eligibility

About

The purpose of the study is to pilot test a multi-modal smoking cessation and relapse prevention intervention with the lung cancer patient population and to obtain preliminary data on its feasibility.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Smoked at least 100 cigarettes in lifetime
• Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days)
• Diagnosis of lung cancer
• Able to read and write English
• Not currently enrolled in a smoking cessation program
• Has a working telephone
• Has a valid home address

Exclusion criteria

• Current use of tobacco cessation medications
• Another household member enrolled in this study
• Contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff
• Moffitt clinical trial participant at time of enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Group 1: Usual Care

Active Comparator group

Description:

Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges).

Treatment:

Drug: Nicotine patch and lozenges

Behavioral: Florida Tobacco Quitline

Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention

Experimental group

Description:

Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.

Treatment:

Drug: Nicotine patch and lozenges

Behavioral: Access to a web-based video

Behavioral: Telephone counseling sessions

Behavioral: Florida Tobacco Quitline