NCT02282969

Brief Summary

Objectives: This protocol addresses the first phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted for the larger, comparative study. In this initial development phase, our prototype patient decision aid will be updated to reflect current guidelines about lung cancer screening. The updated aid will then be pilot-tested in a new sample of patients. In addition, several of the study measures will be refined and further developed in preparation for the larger study. The specific aims of the measures and decision aid development phase of this project are as follows: Update the aid to reflect current screening guidelines and refine the aid via cognitive testing with patients/smokers; and pilot test the updated aid for acceptability with patients/smokers. Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new measure with patients/smokers, and evaluate the reliability of the new measure in a sample patients/smokers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2014Aug 2028

Study Start

First participant enrolled

July 11, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

14.2 years

First QC Date

October 31, 2014

Last Update Submit

January 16, 2026

Conditions

Health Knowledge, Attitudes, Practice

Keywords

Cancer PreventionSmokersQuit smokingInterviewsQuestionnairesSurveysLung cancer screeningPatient decision aid

Outcome Measures

Primary Outcomes (1)

  • Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge)

    Data from interviews and questionnaires reviewed to assess participant knowledge regarding lung cancer screening and decision aid.

    1 Month

Study Arms (1)

Lung Cancer Screening Decision Aids

Participants are asked to look over education materials about lung cancer screening, and interviewed. Some participants will look at a video patient decision aid, with an interview and questionnaire completion. Some participants complete lung cancer screening knowledge questionnaire at first visit, and then again in one month.

Behavioral: InterviewsBehavioral: Questionnaires

Interventions

InterviewsBEHAVIORAL

Interviews performed by study staff encompassing lung cancer screening and patient decision aids.

Lung Cancer Screening Decision Aids
QuestionnairesBEHAVIORAL

Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.

Also known as: Surveys
Lung Cancer Screening Decision Aids

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants recruited from Houston and Galveston areas.

You may qualify if:

  • Men and women 55 to 80 years of age.
  • Participants must speak English.
  • Current smoker or quit smoking within the past 15 years.

You may not qualify if:

  • \. History of lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Behavior

Interventions

Interviews as TopicSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Volk, PHD

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • Suzanne Linder, PHD

    The University of Texas Medical Branch at Galveston

    PRINCIPAL INVESTIGATOR

  • Paul Cinciripini, PHD, MS, BS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Volk, PHD

CONTACT

713-563-2509BVolk@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 5, 2014

Study Start

July 11, 2014

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(2)