Lung NeoplasmsLuCaS-DANCT02790866
Development and Feasibility Testing of a Lung Cancer Screening Decision Aid
A study testing LuCaS Decision Aid and NCI Website in people with Lung Neoplasms, run by Jamie Studts at 2 sites in United States.
Trial summary
This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- LuCaS Decision Aid and NCI Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to Dec 2016
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 40 years of age
- history of 20 or more pack years of smoking
- ability to read and understand English
- must have a personal phone
- must have Internet access
Who cannot join
- reporting or demonstrating significant psychological distress
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40536-0086
University of Miami (FL)
Miami, Florida, 33136
About this study
This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.
Read the detailed description
The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits.
To address this rapidly emerging public health challenge, this research has developed a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on the investigators previous studies exploring LCS decision making and other recent research.
The specific aim of the currently proposed research are to conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. Investigators will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT.
- Conditions
- Lung Neoplasms
- Being tested
- LuCaS Decision Aid, NCI Website
- Keywords
- Decision Aid, Informed Decision Making, Shared Decision making, Screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuCaS Decision AidBehavioural
Web-based Lung Cancer Screening Decision Aid
NCI WebsiteBehavioural
NCI Website on Lung Cancer Screening
| Study group | Role | What they receive |
|---|---|---|
| LuCaS Decision Aid | Experimental | Access to LuCaS, a web-based lung cancer screening decision aid Receives: Behavioral: LuCaS Decision Aid |
| NCI Website | Active comparator | Access to NCI website on lung cancer screening Receives: Behavioral: NCI Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access Rate POST
Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
Measured: Two Weeks (POST)
Recommendation Rate POST
Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening
Measured: Two Weeks (POST)
Satisfaction Rate POST
Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Measured: Two Weeks (POST)
Continued Access Rate POST
Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website
Measured: Two Weeks (POST)
Retention Rate POST
Percentage of participants who complete the POST survey
Measured: Two Weeks (POST)
Retention Rate FOL
Percentage of participants who complete the FOL survey
Measured: Four Months (FOL)
Secondary outcomes (4)
Recommendation Rate FOL
Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening
Measured: Four Months (FOL)
Satisfaction Rate FOL
Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Measured: Four Months (FOL)
Continued Access Rate FOL
Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website
Measured: Four Months (FOL)
Access Rate FOL
Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
Measured: Four Months (FOL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamie Studts
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor-investigator, Jamie Studts, University of Kentucky
- Investigators
- Jamie L Studts, PhD, Principal investigator, University of KentuckyMargaret M Byrne, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790866
- Sponsor's protocol ID
- 15-0001-P1H
- Acronym
- LuCaS-DA
- Status last verified
- Apr 2019
- First submitted
- 16 May 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of a Lung Cancer Screening Decision Aid
- ClinicalTrials.gov ID
- NCT02790866
- Acronym / sponsor ID
- LuCaS-DA / 15-0001-P1H
- Conditions
- Lung Neoplasms
- Keywords
- Decision Aid, Informed Decision Making, Shared Decision making, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jamie StudtsUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jun 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 and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.
Detailed description
The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits.
To address this rapidly emerging public health challenge, this research has developed a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on the investigators previous studies exploring LCS decision making and other recent research.
The specific aim of the currently proposed research are to conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. Investigators will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LuCaS Decision Aid | Experimental | Behavioral: LuCaS Decision AidAccess to LuCaS, a web-based lung cancer screening decision aid |
| NCI Website | Active comparator | Behavioral: NCI WebsiteAccess to NCI website on lung cancer screening |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 40 years of age
- history of 20 or more pack years of smoking
- ability to read and understand English
- must have a personal phone
- must have Internet access
Key exclusion criteria (1 listed)
- reporting or demonstrating significant psychological distress
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 |
|---|---|---|
| LuCaS Decision AidWeb-based Lung Cancer Screening Decision Aid | Behavioural | LuCaS Decision Aid |
| NCI WebsiteNCI Website on Lung Cancer Screening | Behavioural | NCI Website |
Primary outcome
Access Rate POST
Time frame: Two Weeks (POST)
Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
Recommendation Rate POST
Time frame: Two Weeks (POST)
Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening
Satisfaction Rate POST
Time frame: Two Weeks (POST)
Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Continued Access Rate POST
Time frame: Two Weeks (POST)
Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website
Retention Rate POST
Time frame: Two Weeks (POST)
Percentage of participants who complete the POST survey
Retention Rate FOL
Time frame: Four Months (FOL)
Percentage of participants who complete the FOL survey
4 secondary outcomes
Recommendation Rate FOL
Time frame: Four Months (FOL)
Satisfaction Rate FOL
Time frame: Four Months (FOL)
Continued Access Rate FOL
Time frame: Four Months (FOL)
Access Rate FOL
Time frame: Four Months (FOL)
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 3 Apr 2019.
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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.
Jamie L Studts, PhD principal investigator
University of Kentucky
Margaret M Byrne, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuCaS Decision Aid and NCI Website in people with Lung Neoplasms, run by Jamie Studts at 2 sites 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 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Access Rate POST (time frame: Two Weeks (POST)). The study lists 6 primary outcomes in all. 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 Apr 2019.