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
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