NCT04595422

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jul 2020Oct 2026

Study Start

First participant enrolled

July 2, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

July 15, 2020

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • Overall lung cancer screening rate

    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.

    Up to 6 months

Study Arms (2)

Call center staff (educational intervention)

EXPERIMENTAL

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

Other: Educational InterventionOther: 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.

Other: Educational InterventionOther: Questionnaire Administration

Interventions

Undergo training consisting of a 60-minute educational session

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Call center staff (educational intervention)

Complete questionnaire

Callers substudy (LCS educational materials, questionnaire)

Ancillary studies

Call center staff (educational intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • QUITLINE CALL CENTER STAFF
  • Staff member of a quitline
  • Aged 18 years and above
  • 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

You may not qualify if:

  • History of lung cancer by self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Early Intervention, EducationalEducational StatusMethods

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Robert J Volk

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

October 20, 2020

Study Start

July 2, 2020

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations