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Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04595422
Collaborator
National Cancer Institute (NCI) (NIH)
800
Enrollment
1
Location
2
Arms
51
Anticipated Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Educational Intervention
  • Other: Questionnaire Administration
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines
Actual Study Start Date :
Jul 2, 2020
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Call center staff (educational intervention)

Participants undergo training consisting of a 60-minute educational session.

Other: Educational Intervention
Undergo training consisting of a 60-minute educational session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Survey Administration
    Ancillary studies
    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.

    Other: Educational Intervention
    Receive lung cancer screening educational materials
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Questionnaire Administration
    Complete questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Content from communications (email, phone, monthly calls) [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.

    2. Healthcare sector perspective [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.

    3. Reach [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

    4. Overall lung cancer screening rate [Up to 6 months]

    5. Effectiveness (Caller Substudy) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Robert J Volk, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04595422
    Other Study ID Numbers:
    • 2020-0013
    • NCI-2020-03812
    • 2020-0013
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Feb 10, 2022