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NCT Number: NCT07382557

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

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).

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Robert Volk, PHD

CONTACT

[email protected]

713-563-2509

Robert Volk, PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Surveys

Other

Investigators will answer surveys about their lung cancer screening practices

Focus groups

Other

Participants will participate in focus groups about information they need in order to decide about lung cancer screening

Cognitive Interviews

Other

Participants will participate in interviews about their understanding of the adapted video script

Lung cancer screening decision aid video

Behavioral

Participants take surveys before and after watching the intervention video

Colon cancer screening video

Behavioral

Participants take surveys before and after watching the control video

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Volk, PHD

CONTACT

[email protected]

(713) 563-2509

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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