SmokingEarly Phase 1NCT04200534
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)
A Early Phase 1 study testing Best Practice, Nicotine Patch and Quality-of-Life Assessment in people with Smoking and Lung Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. Read more about this study
- Who is it for?
- Ages 55 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Lung Cancer
- What is being tested?
- Best Practice, Nicotine Patch and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jul 2020to 28 Feb 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 55 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS: Primary care patients
- PATIENTS: Upcoming primary care office visit
- PATIENTS: Current smoker
- PATIENTS: 30 plus (+) pack-year smoking history
- PATIENTS: English-speaking
- PROVIDERS: Primary health care providers
- PROVIDERS: Provide care to adults
Who cannot join
- PATIENTS: History of lung cancer by self-report
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Medical Branch
Galveston, Texas, 77555-0565
M D Anderson Cancer Center
Houston, Texas, 77030
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
About this study
Official title: Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial
This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.
Read the detailed description
PRIMARY OBJECTIVE:
- Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.
SECONDARY OBJECTIVES:
- Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.
II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
After completion of study, participants are followed up at 1, 8, and 12 weeks.
- Conditions
- Smoking, Lung Cancer
- Being tested
- Best Practice, Nicotine Patch, Quality-of-Life Assessment, Questionnaire Administration, Tobacco Cessation Counseling
- Keywords
- current smoker, health care provider, primary care doctor
- Medical subject headings
- Smoking, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care counseling
Nicotine PatchDrug
Also called NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Given nicotine patches
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Tobacco Cessation CounselingOther
Receive counseling over the phone
| Study group | Role | What they receive |
|---|---|---|
| Group I (centralized care strategy) | Experimental | Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches. Receives: Drug: Nicotine Patch; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling |
| Group II (usual care) | Active comparator | Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence Questionnairre
Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)
Measured: Up to 12 weeks
Lung Cancer Screening 12 items version
Knowledge of lung cancer screening and benefits of smoking cessation
Measured: Up to 12 weeks
Secondary outcomes (5)
Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study
Assessment of the reach of the intervention
Measured: Up to 12 weeks
Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).
Assessment of the feasibility of implementing the intervention
Measured: Up to 12 weeks
Fidelity checklist (11 items)
Assessment of the feasibility of implementing the intervention
Measured: Up to 12 weeks
EuroQoL-5 dimensions
Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)
Measured: Up to 12 weeks
Costs of implementing any smoking cessation plus shared decision making intervention
Costs of personnel, hardware, and delivering materials to participants
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start31 Jul 2020
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Robert J Volk, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200534
- Sponsor's protocol ID
- 2019-0265
- Other IDs
- NCI-2019-05127, 2019-0265
- Status last verified
- Mar 2025
- First submitted
- 19 Aug 2019
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lowenstein LM, Shih YT, Minnix J, Lopez-Olivo MA, Maki KG, Kypriotakis G, Leal VB, Shete SS, Fox J, Nishi SP, Cinciripini PM, Volk RJ. A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening. Contemp Clin Trials. 2023 May;128:107141. doi: 10.1016/j.cct.2023.107141. Epub 2023 Mar 5.
PubMed 36878389
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT04200534
- Acronym / sponsor ID
- 2019-0265
- Conditions
- Smoking, Lung Cancer
- Keywords
- current smoker, health care provider, primary care doctor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 358 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Research Institute of Texas
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Dec 2019 (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.
This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.
Detailed description
PRIMARY OBJECTIVE:
- Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.
SECONDARY OBJECTIVES:
- Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.
II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
After completion of study, participants are followed up at 1, 8, and 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (centralized care strategy) | Experimental | Drug: Nicotine Patch, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Tobacco Cessation CounselingParticipants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches. |
| Group II (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PATIENTS: Primary care patients
- PATIENTS: Upcoming primary care office visit
- PATIENTS: Current smoker
- PATIENTS: 30 plus (+) pack-year smoking history
- PATIENTS: English-speaking
Key exclusion criteria (1 listed)
- PATIENTS: History of lung cancer by self-report
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care counseling | Other | Group II (usual care) |
| Nicotine PatchAlso: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal PatchGiven nicotine patches | Drug | Group I (centralized care strategy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (centralized care strategy), Group II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Group I (centralized care strategy), Group II (usual care) |
| Tobacco Cessation CounselingReceive counseling over the phone | Other | Group I (centralized care strategy) |
Primary outcome
Smoking abstinence Questionnairre
Time frame: Up to 12 weeks
Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)
Lung Cancer Screening 12 items version
Time frame: Up to 12 weeks
Knowledge of lung cancer screening and benefits of smoking cessation
5 secondary outcomes
Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study
Time frame: Up to 12 weeks
Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).
Time frame: Up to 12 weeks
Fidelity checklist (11 items)
Time frame: Up to 12 weeks
EuroQoL-5 dimensions
Time frame: Up to 12 weeks
Costs of implementing any smoking cessation plus shared decision making intervention
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 36878389Lowenstein LM, Shih YT, Minnix J, Lopez-Olivo MA, Maki KG, Kypriotakis G, Leal VB, Shete SS, Fox J, Nishi SP, Cinciripini PM, Volk RJ. A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening. Contemp Clin Trials. 2023 May;128:107141. doi: 10.1016/j.cct.2023.107141. Epub 2023 Mar 5.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Robert J Volk principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Best Practice, Nicotine Patch and Quality-of-Life Assessment in people with Smoking and Lung Cancer, run by M.D. Anderson Cancer Center at 3 sites 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Smoking abstinence Questionnairre (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04200534, which also lists 1 linked publication.
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 22 Aug 2025; AzTrials last refreshed its copy on 5 Nov 2026.