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

NCT05362318 | Completed

• 1 other identifier: MCC-21108
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Tobacco Use; Lung Cancer

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants who meet inclusion criteria

  Percentage of participants who meet inclusion criteria

  Baseline

• Percentage of participants who agree to participate in the study

  Percentage of participants who agree to participate in the study

  Baseline

• Percentage of participants completing baseline assessment

  Percentage of participants completing baseline assessment

  Baseline

• Percentage of participants completing the 3 month follow-up assessments

  Percentage of participants completing the 3 month follow-up assessments

  at 3 months

• Percentage of participants completing the 6 month follow-up assessments

  Percentage of participants completing the 6 month follow-up assessments

  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.

  at 6 months

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

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

  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

  at 3 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

  at 6 months

Study Arms (2)

Group 1: Usual Care

ACTIVE COMPARATOR

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).

Drug: Nicotine patch and lozenges; Behavioral: Florida Tobacco Quitline

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

EXPERIMENTAL

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.

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

Interventions

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

Group 1: Usual Care; Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention

Telephone counseling sessions BEHAVIORAL

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

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

Access to a web-based video BEHAVIORAL

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

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

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.

Group 1: Usual Care; Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33617, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Lung Neoplasms

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Vani N Simmons, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Jennifer I Vidrine, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 5, 2022
• Study Start: June 7, 2021
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)