Lung CancerNCT07382557
Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System
A study testing Surveys, Focus groups and Cognitive Interviews in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Surveys, Focus groups and Cognitive Interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Robert Volk, PHD, 713-563-2509, bvolk@mdanderson.org
Robert Volk, PHD
About this study
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).
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Surveys, Focus groups, Cognitive Interviews, Lung cancer screening decision aid video, Colon cancer screening video
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Investigators will answer surveys about their lung cancer screening practices
Focus groupsOther
Participants will participate in focus groups about information they need in order to decide about lung cancer screening
Cognitive InterviewsOther
Participants will participate in interviews about their understanding of the adapted video script
Lung cancer screening decision aid videoBehavioural
Participants take surveys before and after watching the intervention video
Colon cancer screening videoBehavioural
Participants take surveys before and after watching the control video
| Study group | Role | What they receive |
|---|---|---|
| Needs Assessment: Provider Survey (Aim 1) | Other | Up to 200 physicians and other health professionals Receives: Other: Surveys |
| Needs Assessment: Patient/Family member Focus Groups (Aim 1) | Other | Up to 20 participants who speak English or Spanish Receives: Other: Focus groups |
| Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1) | Other | Up to 40 participants who speak English or Spanish Receives: Other: Cognitive Interviews |
| Pilot Study: Intervention Patients (Aim 2) | Experimental | Up to 50 participants (25 English speakers, 25 Spanish speakers) Receives: Behavioral: Lung cancer screening decision aid video |
| Pilot Study: Control Patients (Aim 2) | Placebo comparator | Up to 50 participants (25 English speakers, 25 Spanish speakers) Receives: Behavioral: Colon cancer screening video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start29 Sep 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Vok, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382557
- Sponsor's protocol ID
- 2022-0383
- Status last verified
- Jan 2026
- First submitted
- 30 Jun 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System
- ClinicalTrials.gov ID
- NCT07382557
- Acronym / sponsor ID
- 2022-0383
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Needs Assessment: Provider Survey (Aim 1) | Other | Other: SurveysUp to 200 physicians and other health professionals |
| Needs Assessment: Patient/Family member Focus Groups (Aim 1) | Other | Other: Focus groupsUp to 20 participants who speak English or Spanish |
| Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1) | Other | Other: Cognitive InterviewsUp to 40 participants who speak English or Spanish |
| Pilot Study: Intervention Patients (Aim 2) | Experimental | Behavioral: Lung cancer screening decision aid videoUp to 50 participants (25 English speakers, 25 Spanish speakers) |
| Pilot Study: Control Patients (Aim 2) | Placebo comparator | Behavioral: Colon cancer screening videoUp to 50 participants (25 English speakers, 25 Spanish speakers) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysInvestigators will answer surveys about their lung cancer screening practices | Other | Needs Assessment: Provider Survey (Aim 1) |
| Focus groupsParticipants will participate in focus groups about information they need in order to decide about lung cancer screening | Other | Needs Assessment: Patient/Family member Focus Groups (Aim 1) |
| Cognitive InterviewsParticipants will participate in interviews about their understanding of the adapted video script | Other | Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1) |
| Lung cancer screening decision aid videoParticipants take surveys before and after watching the intervention video | Behavioural | Pilot Study: Intervention Patients (Aim 2) |
| Colon cancer screening videoParticipants take surveys before and after watching the control video | Behavioural | Pilot Study: Control Patients (Aim 2) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Vok, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys, Focus groups and Cognitive Interviews in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Volk, PHD ((713) 563-2509, bvolk@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs). (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.