Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System

January 27, 2026 updated by: M.D. Anderson Cancer Center
The goal of the study is to adapt and test a participant decision aid about lung cancer screening for use with patients in theHarris Health System (HHS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study has two phases. In the first phase, the investigators will conduct a cultural and linguistic adaptation of a patient decision aid video on lung cancer screening for use with patients with low health literacy in English and Spanish. They will produce adapted decision aid videos and written educational materials about lung cancer screening. They will survey providers about their lung cancer screening practices, conduct focus groups to learn what patients want to know about screening, and perform cognitive interviews with patients to make sure the adapted videos and educational materials are easy to understand.

In the second phase, the investigators will test the adapted lung cancer screening decision aid videos in English and Spanish to determine acceptability and impact of the aids on decision making outcomes. Patients will be randomized to evaluate an adapted video decision aid intervention or a control condition.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M. D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Robert Volk, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 50-80 years of age
  2. Current smokers or smokers who have quit less than 15 years ago
  3. Speak either English or Spanish
  4. No history of lung cancer
  5. Family member of someone with a history of smoking AND lung cancer

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Needs Assessment: Provider Survey (Aim 1)
Up to 200 physicians and other health professionals
Other: Surveys
Investigators will answer surveys about their lung cancer screening practices
Other: Needs Assessment: Patient/Family member Focus Groups (Aim 1)
Up to 20 participants who speak English or Spanish
Other: Focus groups
Participants will participate in focus groups about information they need in order to decide about lung cancer screening
Other: Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1)
Up to 40 participants who speak English or Spanish
Other: Cognitive Interviews
Participants will participate in interviews about their understanding of the adapted video script
Experimental: Pilot Study: Intervention Patients (Aim 2)
Up to 50 participants (25 English speakers, 25 Spanish speakers)
Behavioral: Lung cancer screening decision aid video
Participants take surveys before and after watching the intervention video
Placebo Comparator: Pilot Study: Control Patients (Aim 2)
Up to 50 participants (25 English speakers, 25 Spanish speakers)
Behavioral: Colon cancer screening video
Participants take surveys before and after watching the control video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Adverse Events (AEs).
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Robert Vok, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

June 30, 2025

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0383

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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