Neoplasm of LungNCT04432753
Effect of Incidental Findings Information on Lung Cancer Screening Intent
A study testing Lung Cancer Screening Decision Aid with Incidental Findings Information and Lung Cancer Screening Decision Aid without Incidental Findings Information in people with Neoplasm of Lung and Decision Support Techniques, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasm of Lung, Decision Support Techniques, Mass Screening
- What is being tested?
- Lung Cancer Screening Decision Aid with Incidental Findings Information and Lung Cancer Screening Decision Aid without Incidental Findings Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 22 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55-80 year old male or female
- Current or former smoker who quit within the last 15 years
- At least 30 pack years of smoking
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial
This online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. Participants will view either a decision aid with incidental findings information or without and indicate their intent to pursue lung cancer screening.
Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen among participants.
- Being tested
- Lung Cancer Screening Decision Aid with Incidental Findings Information, Lung Cancer Screening Decision Aid without Incidental Findings Information
- Keywords
- Incidental Findings
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Cancer Screening Decision Aid with Incidental Findings InformationBehavioural
The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.
Lung Cancer Screening Decision Aid without Incidental Findings InformationBehavioural
The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid with incidental findings information | Experimental | Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening. Receives: Behavioral: Lung Cancer Screening Decision Aid with Incidental Findings Information |
| Decision aid without incidental findings information | Active comparator | Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening. Receives: Behavioral: Lung Cancer Screening Decision Aid without Incidental Findings Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of individuals who plan to pursue lung cancer screening
This will be assessed by a survey item where participants indicate their response to a statement of whether they plan to pursue lung cancer screening, with answer choices being strongly agree, agree, disagree and strongly disagree. Comparison between the intervention and control groups will be made.
Measured: Day 1
Secondary outcomes (6)
Mean score on scale of lung cancer screening knowledge
Lung cancer screening knowledge tested by 6 multiple choice questions on facts of the benefit and harms of screening. The questions will be answered before and after participants watch a lung cancer screening decision aid. Scores will be determined by the number of correct answers for questions.
Measured: Day 1
Mean rating of benefit and harms of screening
Participants will rate (Likert 1-5 scale with 1 being less important and 5 being more important) 6 lung cancer screening benefits and harms on importance to them.
Measured: Day 1
Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last
Participants will rank six lung cancer screening benefits and harms.
Measured: Day 1
Mean ranking of benefit and harms of screening
Participants will rank six lung cancer screening benefits and harms.
Measured: Day 1
Percentage of time each lung cancer screening harm is ranked highest of the five potential harms
Participants will rank six lung cancer screening benefits and harms.
Measured: Day 1
Mean ranking of incidental findings attribute
Participants will rank six lung cancer screening benefits and harms, including one on incidental findings. Comparison of mean ranking will be made between the intervention and control groups.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start16 Jul 2020
- Primary completion22 Aug 2020
- Study completion22 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- UNC Cecil G. Sheps Center for Health Services Research
- Responsible party
- Sponsor
- Investigators
- Stephen Clark, MD, Principal investigator, University of North Carolina, Chapel HillDaniel Jonas, MD, MPH, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432753
- Sponsor's protocol ID
- 19-2709
- Status last verified
- Dec 2020
- First submitted
- 28 May 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clark SD, Reuland DS, Brenner AT, Jonas DE. Effect of Incidental Findings Information on Lung Cancer Screening Intent: a Randomized Controlled Trial. J Gen Intern Med. 2022 Nov;37(14):3676-3683. doi: 10.1007/s11606-022-07409-4. Epub 2022 Feb 2.
PubMed 35113322
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04432753
- Acronym / sponsor ID
- 19-2709
- Keywords
- Incidental Findings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- UNC Cecil G. Sheps Center for Health Services Research
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 22 Aug 2020 (actual)
- Study completion
- 22 Aug 2020 (actual)
- First posted
- 16 Jun 2020 (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.
This online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. Participants will view either a decision aid with incidental findings information or without and indicate their intent to pursue lung cancer screening.
Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen among participants.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid with incidental findings information | Experimental | Behavioral: Lung Cancer Screening Decision Aid with Incidental Findings InformationParticipants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening. |
| Decision aid without incidental findings information | Active comparator | Behavioral: Lung Cancer Screening Decision Aid without Incidental Findings InformationParticipants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 55-80 year old male or female
- Current or former smoker who quit within the last 15 years
- At least 30 pack years of smoking
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Lung Cancer Screening Decision Aid with Incidental Findings InformationThe intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening. | Behavioural | Decision aid with incidental findings information |
| Lung Cancer Screening Decision Aid without Incidental Findings InformationThe intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings. | Behavioural | Decision aid without incidental findings information |
Primary outcome
Percentage of individuals who plan to pursue lung cancer screening
Time frame: Day 1
This will be assessed by a survey item where participants indicate their response to a statement of whether they plan to pursue lung cancer screening, with answer choices being strongly agree, agree, disagree and strongly disagree. Comparison between the intervention and control groups will be made.
6 secondary outcomes
Mean score on scale of lung cancer screening knowledge
Time frame: Day 1
Mean rating of benefit and harms of screening
Time frame: Day 1
Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last
Time frame: Day 1
Mean ranking of benefit and harms of screening
Time frame: Day 1
Percentage of time each lung cancer screening harm is ranked highest of the five potential harms
Time frame: Day 1
Mean ranking of incidental findings attribute
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 35113322Clark SD, Reuland DS, Brenner AT, Jonas DE. Effect of Incidental Findings Information on Lung Cancer Screening Intent: a Randomized Controlled Trial. J Gen Intern Med. 2022 Nov;37(14):3676-3683. doi: 10.1007/s11606-022-07409-4. Epub 2022 Feb 2.
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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. This study is not recruiting at the moment.
Stephen Clark, MD principal investigator
University of North Carolina, Chapel Hill
Daniel Jonas, MD, MPH study director
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Cancer Screening Decision Aid with Incidental Findings Information and Lung Cancer Screening Decision Aid without Incidental Findings Information in people with Neoplasm of Lung and Decision Support Techniques, run by UNC Lineberger Comprehensive 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of individuals who plan to pursue lung cancer screening (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04432753, which also lists 1 linked publication.
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 10 Dec 2020.