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CompletedNCT05362318Updated Apr 6, 2026

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

An interventional study of Nicotine patch and lozenges and Telephone counseling sessions in Smoking, Tobacco Use and Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking
  • Tobacco Use
  • Lung Cancer
03

In context

Smoking

268 studies on the registry are indexed under Smoking; 136 are open to participants now.

This study's enrollment of 21 is below the median of 120 across 211 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    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).

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

  • Experimental
    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.

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

Interventions

  • DrugNicotine patch and lozenges

    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

  • BehavioralTelephone counseling sessions

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

  • BehavioralAccess to a web-based video

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

  • BehavioralFlorida Tobacco Quitline

    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.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants who meet inclusion criteria

    Percentage of participants who meet inclusion criteria

    Time frame: Baseline

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

    Percentage of participants who agree to participate in the study

    Time frame: Baseline

  3. Percentage of participants completing baseline assessment

    Percentage of participants completing baseline assessment

    Time frame: Baseline

  4. Percentage of participants completing the 3 month follow-up assessments

    Percentage of participants completing the 3 month follow-up assessments

    Time frame: at 3 months

  5. Percentage of participants completing the 6 month follow-up assessments

    Percentage of participants completing the 6 month follow-up assessments

    Time frame: at 6 months

  6. 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

  7. 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

  8. 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

    Time frame: at 3 months

  9. 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

    Time frame: at 6 months

07

Study locations

1 site
  • Moffitt Cancer Center
    Tampa, Florida 33617, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05362318
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Responsible party
Sponsor
First posted
May 5, 2022
Start date
Jun 7, 2021
Primary completion
Jan 28, 2023
Completion
Jan 28, 2023
Last update
Apr 6, 2026

Study contacts

Vani N Simmons, PhD
principal investigator · Moffitt Cancer Center
Jennifer I Vidrine, PhD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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