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Clinical Trials/NCT05362318
NCT05362318
Completed
Not Applicable

Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country21 target enrollmentJune 7, 2021

Overview

Phase
Not Applicable
Intervention
Nicotine patch and lozenges
Conditions
Smoking
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
21
Locations
1
Primary Endpoint
Percentage of Participants who meet inclusion criteria
Status
Completed
Last Updated
26 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2021
End Date
January 28, 2023
Last Updated
26 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

Group 1: Usual Care

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).

Intervention: Nicotine patch and lozenges

Group 1: Usual Care

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).

Intervention: Florida Tobacco Quitline

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

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.

Intervention: Nicotine patch and lozenges

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

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.

Intervention: Telephone counseling sessions

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

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.

Intervention: Access to a web-based video

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

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.

Intervention: Florida Tobacco Quitline

Outcomes

Primary Outcomes

Percentage of Participants who meet inclusion criteria

Time Frame: Baseline

Percentage of participants who meet inclusion criteria

Percentage of participants completing baseline assessment

Time Frame: Baseline

Percentage of participants completing baseline assessment

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

Time Frame: 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

Time Frame: Baseline

Percentage of participants who agree to participate in the study

Percentage of participants completing the 3 month follow-up assessments

Time Frame: at 3 months

Percentage of participants completing the 3 month follow-up assessments

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

Time Frame: at 6 months

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

Treatment satisfaction - Acceptability

Time Frame: 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

Time Frame: at 6 months

Percentage of participants completing the 6 month follow-up assessments

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

Time Frame: at 3 months

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

Study Sites (1)

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