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

Not Applicable

Completed

• Conditions: Tobacco Use; Lung Cancer; Smoking
• Interventions: Drug: Nicotine patch and lozenges; Behavioral: Telephone counseling sessions; Behavioral: Access to a web-based video; Behavioral: Florida Tobacco Quitline

• Registration Number: NCT05362318
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-07
• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-05
• Primary Completion: 2023-01-28
• Study Completion: 2023-01-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention	Nicotine patch and lozenges	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.
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention	Telephone counseling sessions	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.
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention	Florida Tobacco Quitline	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.
Group 1: Usual Care	Nicotine patch and lozenges	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).
Group 1: Usual Care	Florida Tobacco Quitline	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).
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention	Access to a web-based video	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who meet inclusion criteria	Baseline	Percentage of participants who meet inclusion criteria
Percentage of participants completing baseline assessment	Baseline	Percentage of participants completing baseline assessment
Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand	at 6 months	Percentage of UC+MAPS+RP participants who viewed the web based video
Percentage of participants who agree to participate in the study	Baseline	Percentage of participants who agree to participate in the study
Percentage of participants completing the 3 month follow-up assessments	at 3 months	Percentage of participants completing the 3 month follow-up assessments
Completion rate of MAPS calls for UC+MAPS+RP participants - Demand	at 6 months	Percentage of MAPS calls completed for UC+MAPS+RP participants
Treatment satisfaction - Acceptability	at 6 months	Mean scores of the Client Satisfaction Questionnaire (SCQ-8) will be used for this measure. The CSQ-8 comprises 8 items for the assessment of treatment satisfaction using a scale from 8 to 32, with higher scores indicating greater satisfaction.
Percentage of participants completing the 6 month follow-up assessments	at 6 months	Percentage of participants completing the 6 month follow-up assessments

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States