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Completed

NCT Number: NCT05362318

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

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.

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Key information

Conditions

Smoking Behavior Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33617, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch and lozenges

Drug

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 Sessions

Behavioral

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 video

Behavioral

Participants will be given web-based access to the relapse prevention video "Surviving Smokefree".

Florida Tobacco Quitline

Behavioral

Participants will receive an offer of enrollment to the Florida Tobacco Quitline which enables participant to speak with a Quit Coach who will assess nicotine addiction and help create a quit plan.

Primary outcomes

  1. Percentage of Participants who meet inclusion criteria

    Time frame: Baseline

    Percentage of participants who meet inclusion criteria

  2. Percentage of participants who agree to participate in the study

    Time frame: Baseline

    Percentage of participants who agree to participate in the study

  3. Percentage of participants completing baseline assessment

    Time frame: Baseline

    Percentage of participants completing baseline assessment

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 5, 2022
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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