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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04595422
Other study ID # 2020-0013
Secondary ID NCI-2020-0381220
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2, 2020
Est. completion date October 1, 2024

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Robert J. Volk
Phone 713-563-0020
Email bvolk@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This implementation study will examine the best ways to refer heavy smokers to information about lung cancer screening.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Educational Intervention
Undergo training consisting of a 60-minute educational session
Educational Intervention
Receive lung cancer screening educational materials
Questionnaire Administration
Complete questionnaire
Survey Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 4 years
Primary Healthcare sector perspective 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
Primary 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 During 6 month implementation period
Primary Overall lung cancer screening rate Up to 6 months
Primary 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. Up to 6 months
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