Lung CancerLungCARENCT03862001
Lung Cancer Screening: A Multilevel Intervention
A study testing LungCARE in people with Lung Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The study will develop and test the feasibility of the Lung Cancer Assessment of Risk and Education (LungCARE) intervention to increase discussions about lung cancer screening between patients and physicians. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- LungCARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 55-80
- smoked at least 30 pack-years in lifetime
- if former smoker, quit smoking within the last 15 years
- English speaker
- no prior history of lung cancer
- did not have a lung cancer screening test within the last year
- PCP does not object to patient's participation
- have a scheduled visit at University of California, San Francisco (UCSF) internal medicine clinics.
Who cannot join
- speaking a language other than English
- has a history of lung cancer
- had a lung cancer screening test within the last year
- PCP objects to patient's participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The study will develop and test the feasibility of the Lung Cancer Assessment of Risk and Education (LungCARE) intervention to increase discussions about lung cancer screening between patients and physicians. This intervention will be designed to reach primary care patients and will be implemented at three levels of the healthcare structure: patient, physician, and system. The patient component includes a short lung cancer screening video and questions regarding screening preferences. Patients will receive immediate feedback in a report (patient report) that summarizes their lung cancer screening preferences and a handout summarizing the educational video. At the physician level, primary care physicians (PCPs) will receive a similar report (physician report), which will be delivered to them prior to the patient visit. The report contains additional information about documenting discussion related to risk, screening, and referrals in the electronic health record (EHR) system (system component). The investigators will develop the LungCARE intervention and have a comparison group that will receive usual care. Preliminary testing of LungCARE will occur via a randomized controlled trial (RCT) at the University of California, San Francisco, General Internal Medicine and Women's Health Primary Care clinics. The RCT will evaluate LungCARE among 50 PCPs and 120 high-risk current and former smoker patients. The investigators will determine whether the intervention is accepted by patients and physicians and whether patients who received LungCARE are more likely to discuss lung cancer screening with their physicians when compared to patients and physicians in the comparison group. The investigators will also determine whether the intervention affects knowledge of lung cancer and low-dose computed tomography (LDCT) screening, perception of risk, and worry about lung cancer in patients when compared to patients in the comparison group. The investigators expect their research to provide specific recommendations that will facilitate patient-physician discussions about LDCT screening and promote shared decision-making among patients and physicians.
- Conditions
- Lung Cancer
- Being tested
- LungCARE
- Keywords
- randomized control trial, lung cancer risk assessment, 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.
LungCAREBehavioural
The LungCARE intervention involves patient and PCP components. The patient component consists of watching a short, educational video, answering questions about lung cancer screening preferences, and receiving a patient report and handout.
The PCP component consists of receiving a similar report (physician report) prior to the patient visit. This report is based on the patient's risk factors and lung cancer screening preferences. It contains additional information about documenting discussions related to risk, screening, and referrals in the electronic medical record system.
| Study group | Role | What they receive |
|---|---|---|
| LungCARE Group | Experimental | The intervention group will receive the LungCARE intervention Receives: Behavioral: LungCARE |
| Comparison Group | No intervention | The comparison group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discussion of lung cancer risk and LDCT screening with PCP
Outcome 1 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer the following yes/no questions: "During your PCP visit, did you discuss...your personal risk of getting lung cancer/the risks and benefits of screening/how often people should be screened/whether you should be screened?", "Did you discuss smoking cigarettes?", "Did you talk about smoking and the risk of lung cancer?", and "Did your doctor refer you to or order a test for lung cancer screening?" Each question will be looked at individually and summed into a single score (0-7). Higher scores indicate an increased discussion of lung cancer risk and LDCT screening.
Three months following the clinic visit, the investigators will review the electronic health records for all patients who signed HIPAA forms. Investigators will gather information about discussion of lung cancer risk and documentation, referrals, counseling, and receipt of LDCT screening.
Measured: Over 3 months
Knowledge of lung cancer screening
Outcome 2 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer true/false questions addressing various screening topics (e.g. annual lung cancer screening, false negative scans, false positive scans, who should be screened, and radiation exposure). Correct answers will be given a score of 1 and incorrect answers will be given a score of 0. Responses for each question will be added up to a single score, ranging between 0 and 10. Lower scores indicate lower knowledge and higher scores indicate higher knowledge.
Measured: Over one week
Perception of lung cancer risk
Outcome 3 will be measured using an adapted Lerman Cancer Worry Scale. The following question will be asked over the course of one week, both prior to and following the clinic visit: "In your opinion, compared to most people of your same age, sex, and race, what are you chances of getting lung cancer someday?" Participants will use a five-point Likert scale ("much higher" [1], "higher" [2], "about the same" [3], "lower" [4], "much lower" [5]) to answer the questions. A higher score indicates a lower perception of lung cancer risk. Responses will be compared between the baseline and follow-up surveys.
Measured: Over one week
Secondary outcomes (1)
Worry about lung cancer
Outcome 4 will be measured using an adapted Lerman Cancer Worry Scale. The following questions will be asked over the course of one week, both prior to and following the clinic visit: "How worried are you about getting lung cancer someday?", "During the past month, how much has your worry about lung cancer affected your mood?", "During the past month, how much has your worry about lung cancer affected your ability to perform your daily activities?", and "During the past month, how often have you thought about your chances of getting lung cancer?" Patients will use a 5-point Likert scale ("a lot" [1], "somewhat" [2], "a little" [3], "not at all" [4]) to answer the first 3 questions and a 4-point Likert scale ("almost all the time" [1], "often" [2], "sometimes" [3], "not at all or rarely" [4]) to answer the last question. Higher scores indicate a lower perception of risk. Each question will be examined individually. Responses will be compared between the baseline and follow-up surveys.
Measured: Over one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Mar 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Model description
- The intervention will involve a randomized control trial (RCT) with an intervention group that receives LungCARE and a comparison group that does not receive LungCARE.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Celia Kaplan, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862001
- Sponsor's protocol ID
- 17-22564
- Acronym
- LungCARE
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21714641Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681-92. doi: 10.1016/s0277-9536(96)00221-3.
PubMed 9032835Henderson S, DeGroff A, Richards TB, Kish-Doto J, Soloe C, Heminger C, Rohan E. A qualitative analysis of lung cancer screening practices by primary care physicians. J Community Health. 2011 Dec;36(6):949-56. doi: 10.1007/s10900-011-9394-2.
PubMed 21442338McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003 Apr;18(2):156-70. doi: 10.1093/her/18.2.156.
PubMed 12729175Poghosyan H, Kennedy Sheldon L, Cooley ME. The impact of computed tomography screening for lung cancer on smoking behaviors: a teachable moment? Cancer Nurs. 2012 Nov-Dec;35(6):446-75. doi: 10.1097/NCC.0b013e3182406297.
PubMed 22209869Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
PubMed 22610500Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
PubMed 28402085Walsh JME, Karliner L, Smith A, Leykin Y, Gregorich SE, Livaudais-Toman J, Velazquez AI, Lowenstein M, Kaplan CP. LungCARE: Encouraging Shared Decision-Making in Lung Cancer Screening-a Randomized Trial. J Gen Intern Med. 2023 Nov;38(14):3115-3122. doi: 10.1007/s11606-023-08189-1. Epub 2023 Aug 31.
PubMed 37653203
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening: A Multilevel Intervention
- ClinicalTrials.gov ID
- NCT03862001
- Acronym / sponsor ID
- LungCARE / 17-22564
- Conditions
- Lung Cancer
- Keywords
- randomized control trial, lung cancer risk assessment, shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Mar 2019 (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 study will develop and test the feasibility of the Lung Cancer Assessment of Risk and Education (LungCARE) intervention to increase discussions about lung cancer screening between patients and physicians. This intervention will be designed to reach primary care patients and will be implemented at three levels of the healthcare structure: patient, physician, and system. The patient component includes a short lung cancer screening video and questions regarding screening preferences. Patients will receive immediate feedback in a report (patient report) that summarizes their lung cancer screening preferences and a handout summarizing the educational video. At the physician level, primary care physicians (PCPs) will receive a similar report (physician report), which will be delivered to them prior to the patient visit. The report contains additional information about documenting discussion related to risk, screening, and referrals in the electronic health record (EHR) system (system component). The investigators will develop the LungCARE intervention and have a comparison group that will receive usual care. Preliminary testing of LungCARE will occur via a randomized controlled trial (RCT) at the University of California, San Francisco, General Internal Medicine and Women's Health Primary Care clinics. The RCT will evaluate LungCARE among 50 PCPs and 120 high-risk current and former smoker patients. The investigators will determine whether the intervention is accepted by patients and physicians and whether patients who received LungCARE are more likely to discuss lung cancer screening with their physicians when compared to patients and physicians in the comparison group. The investigators will also determine whether the intervention affects knowledge of lung cancer and low-dose computed tomography (LDCT) screening, perception of risk, and worry about lung cancer in patients when compared to patients in the comparison group. The investigators expect their research to provide specific recommendations that will facilitate patient-physician discussions about LDCT screening and promote shared decision-making among patients and physicians.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will involve a randomized control trial (RCT) with an intervention group that receives LungCARE and a comparison group that does not receive LungCARE.
| Arm | Type | Receives |
|---|---|---|
| LungCARE Group | Experimental | Behavioral: LungCAREThe intervention group will receive the LungCARE intervention |
| Comparison Group | No intervention | –The comparison group will receive usual care. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 55-80
- smoked at least 30 pack-years in lifetime
- if former smoker, quit smoking within the last 15 years
- English speaker
- no prior history of lung cancer
Key exclusion criteria (4 listed)
- speaking a language other than English
- has a history of lung cancer
- had a lung cancer screening test within the last year
- PCP objects to patient's participation.
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 |
|---|---|---|
| LungCAREThe LungCARE intervention involves patient and PCP components. The patient component consists of watching a short, educational video, answering questions about lung cancer screening preferences, and receiving a patient report and handout. The PCP component consists of receiving a similar report (physician report) prior to the patient visit. This report is based on the patient's risk factors and lung cancer screening preferences. It contains additional information about documenting discussions related to risk, screening, and referrals in the electronic medical record system. | Behavioural | LungCARE Group |
Primary outcome
Discussion of lung cancer risk and LDCT screening with PCP
Time frame: Over 3 months
Outcome 1 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer the following yes/no questions: "During your PCP visit, did you discuss...your personal risk of getting lung cancer/the risks and benefits of screening/how often people should be screened/whether you should be screened?", "Did you discuss smoking cigarettes?", "Did you talk about smoking and the risk of lung cancer?", and "Did your doctor refer you to or order a test for lung cancer screening?" Each question will be looked at individually and summed into a single score (0-7). Higher scores indicate an increased discussion of lung cancer risk and LDCT screening. Three months following the clinic visit, the investigators will review the electronic health records for all patients who signed HIPAA forms. Investigators will gather information about discussion of lung cancer risk and documentation, referrals, counseling, and receipt of LDCT screening.
Knowledge of lung cancer screening
Time frame: Over one week
Outcome 2 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer true/false questions addressing various screening topics (e.g. annual lung cancer screening, false negative scans, false positive scans, who should be screened, and radiation exposure). Correct answers will be given a score of 1 and incorrect answers will be given a score of 0. Responses for each question will be added up to a single score, ranging between 0 and 10. Lower scores indicate lower knowledge and higher scores indicate higher knowledge.
Perception of lung cancer risk
Time frame: Over one week
Outcome 3 will be measured using an adapted Lerman Cancer Worry Scale. The following question will be asked over the course of one week, both prior to and following the clinic visit: "In your opinion, compared to most people of your same age, sex, and race, what are you chances of getting lung cancer someday?" Participants will use a five-point Likert scale ("much higher" [1], "higher" [2], "about the same" [3], "lower" [4], "much lower" [5]) to answer the questions. A higher score indicates a lower perception of lung cancer risk. Responses will be compared between the baseline and follow-up surveys.
1 secondary outcome
Worry about lung cancer
Time frame: Over one week
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 23 Oct 2020.
- 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 9032835Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681-92. doi: 10.1016/s0277-9536(96)00221-3.
- Background: PubMed 21442338Henderson S, DeGroff A, Richards TB, Kish-Doto J, Soloe C, Heminger C, Rohan E. A qualitative analysis of lung cancer screening practices by primary care physicians. J Community Health. 2011 Dec;36(6):949-56. doi: 10.1007/s10900-011-9394-2.
- Background: PubMed 12729175McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003 Apr;18(2):156-70. doi: 10.1093/her/18.2.156.
- Background: PubMed 22209869Poghosyan H, Kennedy Sheldon L, Cooley ME. The impact of computed tomography screening for lung cancer on smoking behaviors: a teachable moment? Cancer Nurs. 2012 Nov-Dec;35(6):446-75. doi: 10.1097/NCC.0b013e3182406297.
- Background: PubMed 22610500Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
- Background: PubMed 28402085Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
- Derived from this study: PubMed 37653203Walsh JME, Karliner L, Smith A, Leykin Y, Gregorich SE, Livaudais-Toman J, Velazquez AI, Lowenstein M, Kaplan CP. LungCARE: Encouraging Shared Decision-Making in Lung Cancer Screening-a Randomized Trial. J Gen Intern Med. 2023 Nov;38(14):3115-3122. doi: 10.1007/s11606-023-08189-1. Epub 2023 Aug 31.
- U.S. Preventive Services Task Force. USPTF Bulletin: U.S. Preventive Services Task Force Issues Draft Recommendation Statement on Screening for Lung Cancer. U.S. Preventive Services Task Force 2013.Link provided by the sponsor.
- Center for Medicare and Medicaid Services. Decision memo for screening for lung cancer with low dose computed tomography (LDCT).Link provided by the sponsor.
- 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.
Celia Kaplan, DrPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LungCARE in people with Lung Cancer, run by University of California, San Francisco 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 8 inclusion and 4 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 23 Oct 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?
Discussion of lung cancer risk and LDCT screening with PCP (time frame: Over 3 months). The study lists 3 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 NCT03862001, which also lists 8 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 23 Oct 2020.