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Lung Cancer Screening: A Multilevel Intervention (LungCARE)

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ClinicalTrials.gov Identifier: NCT03862001
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: LungCARE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Lung Cancer Screening: A Multilevel Intervention
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: LungCARE Group
The intervention group will receive the LungCARE intervention
Behavioral: 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.


No Intervention: Comparison Group
The comparison group will receive usual care.



Primary Outcome Measures :
  1. Discussion of lung cancer risk and LDCT screening with PCP [ Time Frame: Over 3 months ]

    The discussion of lung cancer risk and LDCT screening with PCP 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 combined into a single score.

    Three months following the clinic visit, the investigators will review the electronic health records for all patients who signed HIPAA forms. For the EHR review, investigators will gather information about discussion of lung cancer risk and documentation, referrals, counseling, and receipt of LDCT screening during the patient visit.


  2. Knowledge of lung cancer screening [ Time Frame: Over one week ]
    Knowledge of lung cancer screening 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. Lower scores indicate minimal knowledge and higher scores indicate extensive knowledge.

  3. Perception of lung cancer risk [ Time Frame: Over one week ]
    Perception of lung cancer risk 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: "In your opinion, compared to most people of your same age, sex, and race, what are you chances of getting lung cancer someday?" and "During the past month, how often have you thought about your chances of getting lung cancer?" A five-point Likert scale ranging from "much higher" (1) to "much lower" (5) and a four-point scale ranging from "almost all the time" (1) to "not at all or rarely" (4) will be used, respectively. Higher scores indicate a lower perception of risk. Responses will be compared between the baseline and follow-up surveys.


Secondary Outcome Measures :
  1. Worry about lung cancer [ Time Frame: Over one week ]
    Worry about lung cancer 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?", and "During the past month, how much has your worry about lung cancer affected your ability to perform your daily activities?" Patients will use a five-point Likert scale to answer these questions, ranging from "a lot" (1) to "not at all" (4). Higher scores indicate a lower perception of risk. Responses will be compared between the baseline and follow-up surveys.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) age 55-80, 2) smoked at least 30 pack-years in lifetime, 3) if former smoker, quit smoking within the last 15 years, 4) English speaker, 5) no prior history of lung cancer, 6) did not have a lung cancer screening test within the last year, and 7) PCP does not object to patient's participation. In addition, patient must have a scheduled visit at University of California, San Francisco (UCSF) internal medicine clinics.

Exclusion Criteria:

  • 1) speaking a language other than English, 2) has a history of lung cancer, 3) had a lung cancer screening test within the last year, or 4) PCP objects to patient's participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862001


Contacts
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Contact: Celia P Kaplan, DrPH (415) 502-5601 celia.kaplan@ucsf.edu

Locations
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United States, California
General Internal Medicine at Post Street Not yet recruiting
San Francisco, California, United States, 94143
General Internal Medicine at Sutter Street Not yet recruiting
San Francisco, California, United States, 94143
Women's Health Primary Care Not yet recruiting
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Celia Kaplan, DrPH University of California, San Francisco

Additional Information:
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03862001     History of Changes
Other Study ID Numbers: 17-22564
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
randomized control trial
lung cancer risk assessment
shared decision making

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases