Lung Cancer Screening: A Multilevel Intervention

NCT ID: NCT03862001

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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LungCARE Group

The intervention group will receive the LungCARE intervention

Group Type EXPERIMENTAL

LungCARE

Intervention Type BEHAVIORAL

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.

Comparison Group

The comparison group will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LungCARE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tobacco Related Disease Research Program

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celia Kaplan, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21714641 (View on PubMed)

Charles 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.

Reference Type BACKGROUND
PMID: 9032835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21442338 (View on PubMed)

McBride 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.

Reference Type BACKGROUND
PMID: 12729175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22209869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22610500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28402085 (View on PubMed)

Walsh 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.

Reference Type DERIVED
PMID: 37653203 (View on PubMed)

Related Links

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https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/lung-cancer-screening

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.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274

Center for Medicare and Medicaid Services. Decision memo for screening for lung cancer with low dose computed tomography (LDCT).

Other Identifiers

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17-22564

Identifier Type: -

Identifier Source: org_study_id

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