SmokingNCT05362318
Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free
A study testing Nicotine patch and lozenges, Telephone counseling sessions and Access to a web-based video in people with Smoking and Tobacco Use, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco Use, Lung Cancer
- What is being tested?
- Nicotine patch and lozenges, Telephone counseling sessions and Access to a web-based video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)
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
- Being tested
- Nicotine patch and lozenges, Telephone counseling sessions, Access to a web-based video, Florida Tobacco Quitline
- Medical subject headings
- Smoking, Tobacco Use, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 sessionsBehavioural
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 videoBehavioural
Participants will be given web-based access to the relapse prevention video "Surviving Smokefree".
Florida Tobacco QuitlineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Nicotine patch and lozenges; Behavioral: Telephone counseling sessions; Behavioral: Access to a web-based video; Behavioral: Florida Tobacco Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who meet inclusion criteria
Percentage of participants who meet inclusion criteria
Measured: Baseline
Percentage of participants who agree to participate in the study
Percentage of participants who agree to participate in the study
Measured: Baseline
Percentage of participants completing baseline assessment
Percentage of participants completing baseline assessment
Measured: Baseline
Percentage of participants completing the 3 month follow-up assessments
Percentage of participants completing the 3 month follow-up assessments
Measured: at 3 months
Percentage of participants completing the 6 month follow-up assessments
Percentage of participants completing the 6 month follow-up assessments
Measured: 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.
Measured: at 6 months
Completion rate of MAPS calls for UC+MAPS+RP participants - Demand
Percentage of MAPS calls completed for UC+MAPS+RP participants
Measured: 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
Measured: 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
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start7 Jun 2021
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vani N Simmons, PhD, Principal investigator, Moffitt Cancer CenterJennifer I Vidrine, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362318
- Sponsor's protocol ID
- MCC-21108
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)
- ClinicalTrials.gov ID
- NCT05362318
- Acronym / sponsor ID
- MCC-21108
- Conditions
- Smoking, Tobacco Use, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Usual Care | Active comparator | Drug: Nicotine patch and lozenges, Behavioral: Florida Tobacco QuitlineParticipants 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). |
| Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention | Experimental | Drug: Nicotine patch and lozenges, Behavioral: Telephone counseling sessions, Behavioral: Access to a web-based video, Behavioral: Florida Tobacco QuitlineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patch and lozengesParticipants 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 | Drug | Group 1: Usual Care, Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention |
| Telephone counseling sessionsParticipants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period. | Behavioural | Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention |
| Access to a web-based videoParticipants will be given web-based access to the relapse prevention video "Surviving Smokefree". | Behavioural | Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention |
| Florida Tobacco QuitlineParticipants 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. | Behavioural | Group 1: Usual Care, Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention |
Primary outcome
Percentage of Participants who meet inclusion criteria
Time frame: Baseline
Percentage of participants who meet inclusion criteria
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 baseline assessment
Time frame: Baseline
Percentage of participants completing baseline assessment
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
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
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vani N Simmons, PhD principal investigator
Moffitt Cancer Center
Jennifer I Vidrine, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch and lozenges, Telephone counseling sessions and Access to a web-based video in people with Smoking and Tobacco Use, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who meet inclusion criteria (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.