Clinical trial NCT03862001: Lung Cancer Screening: A Multilevel Intervention
Official title: Lung Cancer Screening: A Multilevel Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: randomized control trial
lung cancer risk assessment
shared decision making
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2019-03-05
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Discussion of lung cancer risk and LDCT screening with PCP
timeFrame: Over 3 months
measure: Knowledge of lung cancer screening
timeFrame: Over one week
measure: Perception of lung cancer risk
timeFrame: Over one week
Secondary outcomes:
measure: Worry about lung cancer
timeFrame: Over one week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Celia Kaplan, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Henderson 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.
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citation: Poghosyan 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.
citation: Bach 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.
citation: Stacey 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.