- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04595422
Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert J. Volk
- Phone Number: 713-563-0020
- Email: bvolk@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Robert J. Volk
- Phone Number: 713-563-0020
-
Principal Investigator:
- Robert J. Volk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) EXCLUSION CRITERIA
- History of lung cancer by self-report
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Call center staff (educational intervention)
Participants undergo training consisting of a 60-minute educational session.
|
Ancillary studies
Undergo training consisting of a 60-minute educational session
Other Names:
Receive lung cancer screening educational materials
Other Names:
|
|
Experimental: Callers substudy (LCS educational materials, questionnaire)
Participants are referred to lung cancer screening educational materials.
Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.
|
Complete questionnaire
Undergo training consisting of a 60-minute educational session
Other Names:
Receive lung cancer screening educational materials
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 4 years
|
|
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.
|
Up to 4 years
|
|
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
|
During 6 month implementation period
|
|
Overall lung cancer screening rate
Time Frame: Up to 6 months
|
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.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert J Volk, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Investigative Techniques
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Socioeconomic Factors
- Population Characteristics
- Methods
- Early Intervention, Educational
- Educational Status
Other Study ID Numbers
- 2020-0013 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-03812 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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