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Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines

Primary Purpose

Lung Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Educational Intervention
Questionnaire Administration
Survey Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Call center staff (educational intervention)

Callers substudy (LCS educational materials, questionnaire)

Arm Description

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

Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.

Outcomes

Primary Outcome Measures

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.
Healthcare sector perspective
As needed, will use a process-flow analysis to identify all resources utilized at each of the step of the program.
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
Overall lung cancer screening rate
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.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2020
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04595422
Brief Title
Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines
Official Title
Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Call center staff (educational intervention)
Arm Type
Experimental
Arm Description
Participants undergo training consisting of a 60-minute educational session.
Arm Title
Callers substudy (LCS educational materials, questionnaire)
Arm Type
Experimental
Arm Description
Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Undergo training consisting of a 60-minute educational session
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive lung cancer screening educational materials
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Content from communications (email, phone, monthly calls)
Description
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.
Time Frame
Up to 4 years
Title
Healthcare sector perspective
Description
As needed, will use a process-flow analysis to identify all resources utilized at each of the step of the program.
Time Frame
Up to 4 years
Title
Reach
Description
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
Time Frame
During 6 month implementation period
Title
Overall lung cancer screening rate
Time Frame
Up to 6 months
Title
Effectiveness (Caller Substudy)
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert J. Volk
Phone
713-563-0020
Email
bvolk@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Volk
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert J. Volk
Phone
713-563-0020
First Name & Middle Initial & Last Name & Degree
Robert J. Volk

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines

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