Lung NeoplasmsNCT02962115
Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
A study testing Decision Aid Invitation in people with Lung Neoplasms, run by Wake Forest University Health Sciences.
Trial summary
This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid. Read more about this study
- Who is it for?
- Ages 55 to 77 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Decision Aid Invitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 31 Mar 2017
- 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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has an active patient portal account
- Scheduled to see a Wake Forest primary care provider within the next 4 weeks
Who cannot join
- Never smokers
- Current or former history of lung cancer
- Receipt of chest CT scan within last 12 months
- Need for a language interpreter
- Presence of disease predicting short life-expectancy
About this study
This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.
Read the detailed description
The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose chest CT scans for lung cancer screening in patients who meet specific criteria. However, many individuals who meet these criteria do not realize they qualify for screening. This study will determine the feasibility of using a clinical informatics approach to systematically identify potential candidates for LDCT screening, reach out to them via the patient portal, and use a web app to provide them with a personalized LDCT screening decision aid and facilitate the ordering of screening tests.
- Conditions
- Lung Neoplasms
- Being tested
- Decision Aid Invitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid InvitationBehavioural
electronic invitation to complete web-based decision aid
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Invitation | Experimental | Electronic invitation to complete a web-based lung cancer screening decision aid Receives: Behavioral: Decision Aid Invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of LDCT screening
Number of participants who received a low-dose chest CT
Measured: 120 days
Secondary outcomes (6)
Read portal invitation
Number of participants who read the portal invitation
Measured: 120 days
Visit web decision aid
Number of participants who visited the study website
Measured: 120 days
Complete web decision aid
Number of participants who complete the lung cancer screening eligibility items
Measured: 120 days
Eligible for LDCT
Number of participants who are confirmed eligible for LDCT by the study website
Measured: 120 days
Interest in LDCT screening
Number of participants who indicate they are interested in receiving LDCT
Measured: 120 days
Appointment for LDCT visit
Number of participants who are scheduled for a lung cancer screening clinic visit or a LDCT exam
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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 Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Miller, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962115
- Sponsor's protocol ID
- IRB00036974
- Other IDs
- CCCWFU 99316
- Status last verified
- Feb 2022
- First submitted
- 19 Oct 2016
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.
PubMed 30625501
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention
- ClinicalTrials.gov ID
- NCT02962115
- Acronym / sponsor ID
- IRB00036974
- Conditions
- Lung Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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 study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.
Detailed description
The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose chest CT scans for lung cancer screening in patients who meet specific criteria. However, many individuals who meet these criteria do not realize they qualify for screening. This study will determine the feasibility of using a clinical informatics approach to systematically identify potential candidates for LDCT screening, reach out to them via the patient portal, and use a web app to provide them with a personalized LDCT screening decision aid and facilitate the ordering of screening tests.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Invitation | Experimental | Behavioral: Decision Aid InvitationElectronic invitation to complete a web-based lung cancer screening decision aid |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has an active patient portal account
- Scheduled to see a Wake Forest primary care provider within the next 4 weeks
Key exclusion criteria (5 listed)
- Never smokers
- Current or former history of lung cancer
- Receipt of chest CT scan within last 12 months
- Need for a language interpreter
- Presence of disease predicting short life-expectancy
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 |
|---|---|---|
| Decision Aid Invitationelectronic invitation to complete web-based decision aid | Behavioural | Decision Aid Invitation |
Primary outcome
Receipt of LDCT screening
Time frame: 120 days
Number of participants who received a low-dose chest CT
6 secondary outcomes
Read portal invitation
Time frame: 120 days
Visit web decision aid
Time frame: 120 days
Complete web decision aid
Time frame: 120 days
Eligible for LDCT
Time frame: 120 days
Interest in LDCT screening
Time frame: 120 days
Appointment for LDCT visit
Time frame: 120 days
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 17 Feb 2022.
- Derived from this study: PubMed 30625501Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.
- Individual participant dataSharing planned: No
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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.
David P Miller, MD, MS principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid Invitation in people with Lung Neoplasms, run by Wake Forest University Health Sciences.
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 5 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Receipt of LDCT screening (time frame: 120 days). 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 NCT02962115, 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 17 Feb 2022.