Lung CancerTIDiLNCT04940221
Testing Informed Decision Making in Lung Cancer Screening
A study testing Shared Decision Making in people with Lung Cancer, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. Read more about this study
- Who is it for?
- Ages 55 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current or former smoker
- Greater than or equal to 30 pack years smoking
Who cannot join
- Prior CT in last year
- Quit smoking greater than 15 years ago
- Current diagnosis of lung cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19718
About this study
Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.
Read the detailed description
Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in 2015. There is a critical need to develop and implement effective strategies to engage high-risk patients in a coordinated program of lung cancer screening, which includes shared-decision making. The investigators proposed to modify and expand a shared decision- counseling intervention previously developed in one primary care practice. The investigators measured lung cancer screening in our intervention group compared to a propensity-matched usual care cohort. The investigators compared patients recruited to patients who are not in order to identify potential sources of disparity in future work and the investigators developed a more intense smoking cessation component. Model interventions for shared-decision making in clinical practice are needed across a wide range of diseases and decisions.
- Conditions
- Lung Cancer
- Being tested
- Shared Decision Making
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision MakingBehavioural
Telephone delivered non-persuasive shared decision-making for lung cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Phone-delivered decision-counseling program for shared decision making in lung cancer screening | Experimental | All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group. Receives: Behavioral: Shared Decision Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Received a Low Dose CT Scan of the Chest
Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start18 Jul 2018
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, University of Delaware, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Heather Bittner Fagan, Christiana Care Health Services
- Investigators
- Heather B Fagan, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940221
- Sponsor's protocol ID
- 603913
- Other IDs
- U54GM104941
- Acronym
- TIDiL
- Status last verified
- Sep 2023
- First submitted
- 9 Jun 2021
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending data analytic support to de-identify data, will share entire study data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Informed Decision Making in Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT04940221
- Acronym / sponsor ID
- TIDiL / 603913
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, University of Delaware, National Institute of General Medical Sciences (NIGMS)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 20 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.
Detailed description
Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in 2015. There is a critical need to develop and implement effective strategies to engage high-risk patients in a coordinated program of lung cancer screening, which includes shared-decision making. The investigators proposed to modify and expand a shared decision- counseling intervention previously developed in one primary care practice. The investigators measured lung cancer screening in our intervention group compared to a propensity-matched usual care cohort. The investigators compared patients recruited to patients who are not in order to identify potential sources of disparity in future work and the investigators developed a more intense smoking cessation component. Model interventions for shared-decision making in clinical practice are needed across a wide range of diseases and decisions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone-delivered decision-counseling program for shared decision making in lung cancer screening | Experimental | Behavioral: Shared Decision MakingAll individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group. |
Who may qualify
- Ages
- 55 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current or former smoker
- Greater than or equal to 30 pack years smoking
Key exclusion criteria (3 listed)
- Prior CT in last year
- Quit smoking greater than 15 years ago
- Current diagnosis of lung cancer
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 |
|---|---|---|
| Shared Decision MakingTelephone delivered non-persuasive shared decision-making for lung cancer screening. | Behavioural | Phone-delivered decision-counseling program for shared decision making in lung cancer screening |
Primary outcome
Number of Patients Who Received a Low Dose CT Scan of the Chest
Time frame: 1 year
Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Pending data analytic support to de-identify data, will share entire study data.
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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.
Heather B Fagan, MD principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making in people with Lung Cancer, run by Christiana Care Health Services 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 2 inclusion and 3 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 18 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Received a Low Dose CT Scan of the Chest (time frame: 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 18 Sep 2023.