Lung NeoplasmsNCT03077230
Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
A study testing Pre/Post Test of a Lung Cancer Screening Decision Aid in people with Lung Neoplasms and Early Detection of Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lung Neoplasms, Early Detection of Cancer, Decision Support Techniques
- What is being tested?
- Pre/Post Test of a Lung Cancer Screening Decision Aid
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to participate in this study:
- Age 55 - 80;
- Current smoker, or former smoker who has less than a 16-year quit history;
- Have at least a 30-pack year smoking history (average packs per day * years smoking); and
- Patient of the Internal Medicine Clinic at University of North Carolina Health Care.
Who cannot join
- All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Ever diagnosed with lung cancer;
- Undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment;
- Coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment;
- Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and
- Had a chest CT scan within the past 18 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Ambulatory Care Center Internal Medicine Clinic
Chapel Hill, North Carolina, 27599
About this study
The primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.
Read the detailed description
Using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.
- Conditions
- Lung Neoplasms, Early Detection of Cancer, Decision Support Techniques, Primary Health Care
- Being tested
- Pre/Post Test of a Lung Cancer Screening Decision Aid
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre/Post Test of a Lung Cancer Screening Decision AidBehavioural
After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.
| Study group | Role | What they receive |
|---|---|---|
| Pre/Post Test of a Lung Cancer Screening Decision Aid | Experimental | Not described Receives: Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decision-making measures of knowledge
We will use descriptive statistics to provide an overview of knowledge at baseline and at follow-up.
- Hypothesis 1: Screening specific knowledge will improve after completing the decision aid.
- Statistical tests:
- Overall knowledge: Treating knowledge as a continuous variable by adding number correct out of 12 items (0-12 possible points), we will perform a Wilcoxon sign rank test to assess change in knowledge between baseline and follow-up
- Individual knowledge items: Using McNemar's test, we will compare the proportion who correctly answered individual knowledge items at baseline and follow-up
Measured: At time of intervention
Change in screening attitudes
We will use descriptive statistics to provide an overview of screening attitudes at baseline and at follow-up.
- Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening attitudes.
Measured: At time of intervention
Change in decisional conflict
We will use descriptive statistics to provide an overview of decisional conflict at baseline and at follow-up.
- Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of decisional conflict.
Measured: At time of intervention
Change in screening intentions
We will use descriptive statistics to provide an overview of screening intentions at baseline and at follow-up.
- Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening intentions.
Measured: At time of intervention
Secondary outcomes (2)
Preliminary estimates on the effect of the decision aid on behavioral outcomes
We will use descriptive statistics (means and proportions) to provide preliminary estimates on the effect of the decision aid on documentation of shared decision-making in the electronic health record and screening behavior at 3 months.
Measured: Within 3 months of intervention
Feasibility of implementing a decision aid intervention in a primary care clinic setting
This is a descriptive and qualitative aim. We will describe measures of feasibility related to time needed to complete surveys, participant ability to navigate decision aid website, number of times assistance is needed to complete surveys/navigate the decision aid website, and type of assistance required.
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 posted10 Mar 2017
- Study startMay 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel S Reuland, MD MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077230
- Sponsor's protocol ID
- LCCC 1506
- Status last verified
- Sep 2017
- First submitted
- 22 Nov 2016
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641Kovalchik SA, Tammemagi M, Berg CD, Caporaso NE, Riley TL, Korch M, Silvestri GA, Chaturvedi AK, Katki HA. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013 Jul 18;369(3):245-254. doi: 10.1056/NEJMoa1301851.
PubMed 23863051Bach PB, Gould MK. When the average applies to no one: personalized decision making about potential benefits of lung cancer screening. Ann Intern Med. 2012 Oct 16;157(8):571-3. doi: 10.7326/0003-4819-157-8-201210160-00524. No abstract available.
PubMed 22893040Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
PubMed 24378917Reuland DS, Cubillos L, Brenner AT, Harris RP, Minish B, Pignone MP. A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak. 2018 Jan 12;18(1):5. doi: 10.1186/s12911-018-0582-1.
PubMed 29325548
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT03077230
- Acronym / sponsor ID
- LCCC 1506
- Conditions
- Lung Neoplasms, Early Detection of Cancer, Decision Support Techniques, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Mar 2017 (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 primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.
Detailed description
Using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre/Post Test of a Lung Cancer Screening Decision Aid | Experimental | Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 55 - 80;
- Current smoker, or former smoker who has less than a 16-year quit history;
- Have at least a 30-pack year smoking history (average packs per day * years smoking); and
- Patient of the Internal Medicine Clinic at University of North Carolina Health Care.
Key exclusion criteria (6 listed)
- All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Ever diagnosed with lung cancer;
- Undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment;
- Coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment;
- Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and
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 |
|---|---|---|
| Pre/Post Test of a Lung Cancer Screening Decision AidAfter completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers. | Behavioural | Pre/Post Test of a Lung Cancer Screening Decision Aid |
Primary outcome
Change in decision-making measures of knowledge
Time frame: At time of intervention
We will use descriptive statistics to provide an overview of knowledge at baseline and at follow-up. * Hypothesis 1: Screening specific knowledge will improve after completing the decision aid. o Statistical tests: * Overall knowledge: Treating knowledge as a continuous variable by adding number correct out of 12 items (0-12 possible points), we will perform a Wilcoxon sign rank test to assess change in knowledge between baseline and follow-up * Individual knowledge items: Using McNemar's test, we will compare the proportion who correctly answered individual knowledge items at baseline and follow-up
Change in screening attitudes
Time frame: At time of intervention
We will use descriptive statistics to provide an overview of screening attitudes at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening attitudes.
Change in decisional conflict
Time frame: At time of intervention
We will use descriptive statistics to provide an overview of decisional conflict at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of decisional conflict.
Change in screening intentions
Time frame: At time of intervention
We will use descriptive statistics to provide an overview of screening intentions at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening intentions.
2 secondary outcomes
Preliminary estimates on the effect of the decision aid on behavioral outcomes
Time frame: Within 3 months of intervention
Feasibility of implementing a decision aid intervention in a primary care clinic setting
Time frame: Through study completion, an average of 1 year
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 20 Sep 2017.
- Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Background: PubMed 23863051Kovalchik SA, Tammemagi M, Berg CD, Caporaso NE, Riley TL, Korch M, Silvestri GA, Chaturvedi AK, Katki HA. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013 Jul 18;369(3):245-254. doi: 10.1056/NEJMoa1301851.
- Background: PubMed 22893040Bach PB, Gould MK. When the average applies to no one: personalized decision making about potential benefits of lung cancer screening. Ann Intern Med. 2012 Oct 16;157(8):571-3. doi: 10.7326/0003-4819-157-8-201210160-00524. No abstract available.
- Background: PubMed 24378917Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
- Derived from this study: PubMed 29325548Reuland DS, Cubillos L, Brenner AT, Harris RP, Minish B, Pignone MP. A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak. 2018 Jan 12;18(1):5. doi: 10.1186/s12911-018-0582-1.
- UNC Lineberger Home PageLink 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. This study is not recruiting at the moment.
Daniel S Reuland, MD MPH principal investigator
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 Pre/Post Test of a Lung Cancer Screening Decision Aid in people with Lung Neoplasms and Early Detection of Cancer, 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 5 inclusion and 6 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 20 Sep 2017. 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?
Change in decision-making measures of knowledge (time frame: At time of intervention). The study lists 4 primary outcomes in all. 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 NCT03077230, which also lists 5 linked publications.
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 20 Sep 2017.