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

H. Lee Moffitt Cancer Center and Research Institute21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Smoking Tobacco Use Lung Cancer

Interventions

Nicotine patch and lozengesDRUG

Participants will receive nicotine patch and lozenges. The regimen will be based on the participant's self-reported smoking rate. At the time of enrollment, a research staff member will determine the proper dose. Participants who smoke \>10 cigarettes/day will receive 8 weeks of 21 mg. patches, 2 weeks of 14 mg. patches, 2 weeks of 7 mg. patches, and 12 weeks of 2 mg. lozenges. Those who smoke \<10 cigarettes/day will receive 8 weeks of 14 mg. patches, 4 weeks of 7 mg patches, and 12 weeks of 2 mg. lozenges

Telephone counseling sessionsBEHAVIORAL

Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.

Access to a web-based videoBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Percentage of Participants who meet inclusion criteria

Percentage of participants who meet inclusion criteria

Time frame: Baseline

Percentage of participants who agree to participate in the study

Time frame: Baseline

Percentage of participants completing baseline assessment

Time frame: Baseline

Percentage of participants completing the 3 month follow-up assessments

Time frame: at 3 months

Percentage of participants completing the 6 month follow-up assessments

Time frame: at 6 months

Treatment satisfaction - Acceptability

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.

Time frame: at 6 months

Completion rate of MAPS calls for UC+MAPS+RP participants - Demand

Percentage of MAPS calls completed for UC+MAPS+RP participants

Time frame: at 6 months

Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand

Percentage of UC+MAPS+RP participants who viewed the web based video

Data from ClinicalTrials.gov

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