Lung CarcinomaNCT04595422
Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines
A study testing Educational Intervention, Questionnaire Administration and Survey Administration in people with Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This implementation study will examine the best ways to refer heavy smokers to information about lung cancer screening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Educational Intervention, Questionnaire Administration and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2020to 31 Oct 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- QUITLINE CALL CENTER STAFF
- Staff member of a quitline
- Aged 18 years and above
- CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) INCLUSION CRITERIA
- Callers 55-80 years of age
- Current smoker, or former smoker with a cessation history of < 15 years
- >= 30 pack-year smoking history
- English-speaking
Who cannot join
- CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) EXCLUSION CRITERIA
- History of lung cancer by self-report
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Robert J. Volk, 713-563-0020
Robert J. Volk
About this study
This implementation study will examine the best ways to refer heavy smokers to information about lung cancer screening.
Read the detailed description
PRIMARY OBJECTIVE:
- To increase the number of smokers eligible for lung cancer screening (LCS) who receive high-quality educational materials about LCS through tobacco quitlines.
OUTLINE:
CALL CENTER STAFF: Participants undergo training consisting of a 60-minute educational session.
CALLERS SUBSTUDY: Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.
- Conditions
- Lung Carcinoma
- Being tested
- Educational Intervention, Questionnaire Administration, Survey Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Undergo training consisting of a 60-minute educational session
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive lung cancer screening educational materials
Questionnaire AdministrationOther
Complete questionnaire
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Call center staff (educational intervention) | Experimental | Participants undergo training consisting of a 60-minute educational session. Receives: Other: Educational Intervention; Other: Survey Administration |
| Callers substudy (LCS educational materials, questionnaire) | Experimental | Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content from communications (email, phone, monthly calls)
Will be content analyzed using Atlas.ti qualitative software according to the adaptation framework from Stirman and colleagues. Will identify 1) who made the modification; 2) what was modified (i.e., content, context, training and evaluation); 3) for whom the modification was made (e.g., individual counselor); 4) context of the modification (e.g., format, setting, personnel, population); and 5) what was the nature of the modification (e.g., adding elements). Will also code for facilitators and barriers that are consistent with the constructs from CFIR. All textual data will be double coded and discussed by the researchers.
Measured: Up to 4 years
Healthcare sector perspective
As needed, will use a process-flow analysis to identify all resources utilized at each of the step of the program.
Measured: Up to 4 years
Reach
The analysis of the data from the logs and surveys will include examining the means, medians, standard deviations, and ranges overall and by state quitline for Reach
Measured: During 6 month implementation period
Overall lung cancer screening rate
Measured: Up to 6 months
Effectiveness (Caller Substudy)
Will be successful if callers who participate in the evaluation answer at least 58 percent (7/12) of the Adapted lung cancer screening (LCS)-12 Knowledge Measure questions correctly and have a PrepDM score of at least 80 (standard deviation [SD] = 17.7), which were observed in the original project.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start2 Jul 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies 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
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert J Volk, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595422
- Sponsor's protocol ID
- 2020-0013
- Other IDs
- NCI-2020-03812, 2020-0013
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines
- ClinicalTrials.gov ID
- NCT04595422
- Acronym / sponsor ID
- 2020-0013
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Oct 2020 (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 implementation study will examine the best ways to refer heavy smokers to information about lung cancer screening.
Detailed description
PRIMARY OBJECTIVE:
- To increase the number of smokers eligible for lung cancer screening (LCS) who receive high-quality educational materials about LCS through tobacco quitlines.
OUTLINE:
CALL CENTER STAFF: Participants undergo training consisting of a 60-minute educational session.
CALLERS SUBSTUDY: Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Call center staff (educational intervention) | Experimental | Other: Educational Intervention, Other: Survey AdministrationParticipants undergo training consisting of a 60-minute educational session. |
| Callers substudy (LCS educational materials, questionnaire) | Experimental | Other: Educational Intervention, Other: Questionnaire AdministrationParticipants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- QUITLINE CALL CENTER STAFF
- Staff member of a quitline
- Aged 18 years and above
- CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) INCLUSION CRITERIA
- Callers 55-80 years of age
Key exclusion criteria (2 listed)
- CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) EXCLUSION CRITERIA
- 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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalUndergo training consisting of a 60-minute educational session | Other | Call center staff (educational intervention) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive lung cancer screening educational materials | Other | Callers substudy (LCS educational materials, questionnaire) |
| Questionnaire AdministrationComplete questionnaire | Other | Callers substudy (LCS educational materials, questionnaire) |
| Survey AdministrationAncillary studies | Other | Call center staff (educational intervention) |
Primary outcome
Content from communications (email, phone, monthly calls)
Time frame: Up to 4 years
Will be content analyzed using Atlas.ti qualitative software according to the adaptation framework from Stirman and colleagues. Will identify 1) who made the modification; 2) what was modified (i.e., content, context, training and evaluation); 3) for whom the modification was made (e.g., individual counselor); 4) context of the modification (e.g., format, setting, personnel, population); and 5) what was the nature of the modification (e.g., adding elements). Will also code for facilitators and barriers that are consistent with the constructs from CFIR. All textual data will be double coded and discussed by the researchers.
Healthcare sector perspective
Time frame: Up to 4 years
As needed, will use a process-flow analysis to identify all resources utilized at each of the step of the program.
Reach
Time frame: During 6 month implementation period
The analysis of the data from the logs and surveys will include examining the means, medians, standard deviations, and ranges overall and by state quitline for Reach
Overall lung cancer screening rate
Time frame: Up to 6 months
Effectiveness (Caller Substudy)
Time frame: Up to 6 months
Will be successful if callers who participate in the evaluation answer at least 58 percent (7/12) of the Adapted lung cancer screening (LCS)-12 Knowledge Measure questions correctly and have a PrepDM score of at least 80 (standard deviation [SD] = 17.7), which were observed in the original project.
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 6 Oct 2026.
- M D Anderson Cancer CenterLink 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.
Robert J Volk principal investigator
M.D. Anderson 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 Educational Intervention, Questionnaire Administration and Survey Administration in people with Lung Carcinoma, run by M.D. Anderson Cancer Center 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 2 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: looking for participants now, as of the sponsor's last update on 6 Oct 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?
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?
Contact Robert J. Volk (713-563-0020, bvolk@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content from communications (email, phone, monthly calls) (time frame: Up to 4 years). The study lists 5 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 Oct 2026.