Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System
1 other identifier
interventional
360
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Sep 2022
Typical duration for not_applicable lung-cancer
1 active site
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 Start
First participant enrolled
September 29, 2022
CompletedFirst Submitted
Initial submission to the registry
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
February 3, 2026
January 1, 2026
4.3 years
June 30, 2025
January 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs).
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
Study Arms (5)
Needs Assessment: Provider Survey (Aim 1)
OTHERUp to 200 physicians and other health professionals
Needs Assessment: Patient/Family member Focus Groups (Aim 1)
OTHERUp to 20 participants who speak English or Spanish
Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1)
OTHERUp to 40 participants who speak English or Spanish
Pilot Study: Intervention Patients (Aim 2)
EXPERIMENTALUp to 50 participants (25 English speakers, 25 Spanish speakers)
Pilot Study: Control Patients (Aim 2)
PLACEBO COMPARATORUp to 50 participants (25 English speakers, 25 Spanish speakers)
Interventions
Investigators will answer surveys about their lung cancer screening practices
Participants will participate in focus groups about information they need in order to decide about lung cancer screening
Participants will participate in interviews about their understanding of the adapted video script
Participants take surveys before and after watching the intervention video
Participants take surveys before and after watching the control video
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Vok, PHD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2025
First Posted
February 3, 2026
Study Start
September 29, 2022
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
February 3, 2026
Record last verified: 2026-01