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DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement (DECIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891602
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : July 30, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Indiana University
Kaiser Permanente
University of North Carolina
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to learn about discussion between clinicians and their patients related to lung screening. Survey answers will be collected from both clinicians and their patients.

Condition or disease Intervention/treatment
Smoking Smoking, Tobacco Smoking, Cigarette Lung Cancer Behavioral: Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale) Behavioral: Patient Trust in the Medical Behavioral: Decision Conflict Scale - Lung Cancer Screening Behavioral: Shared Decision Making Questionnaire - Patient Behavioral: Stage of Readiness for Smoking Cessation - Contemplation Ladder Behavioral: Primary Care Clinicians' Lung Cancer Screening Survey

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Study Type : Observational
Estimated Enrollment : 625 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clinicians
Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients
Behavioral: Primary Care Clinicians' Lung Cancer Screening Survey
Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.

Smokers/Former Smokers
Current smoker or former smoker who has quit within the past 15 years
Behavioral: Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)
Perceived Smoking-Related Stigma will be measured using the 5-item Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale). The response scale is 1 = strongly disagree, to 4 = strongly agree, and scores range from 5 to 25 (high stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.

Behavioral: Patient Trust in the Medical
Medical Mistrust will be measured using the 5-item Patient Trust in the Medical Profession Scale.80 The five-point Likert responses measure the extent to which patients perceive their clinician to be honest, caring more about convenience, thorough and careful, and trusted. The range of scores is 5 to 25 (higher mistrust). Reliability and validity have been well established with a Cronbach"s alpha of 0.84.

Behavioral: Decision Conflict Scale - Lung Cancer Screening
The DCS is a 16-item Likert-response item scale that has been modified for the lung cancer screening and smoking cessation contexts. The DCS was developed by O"Connor,74-75 and validated in many health decisions including breast cancer screening with Cronbach"s alphas ranging from 0.78 to 0.81. 74-75 Despite its name, the DCS measures more than decision conflict to encompass personal perceptions of perceived decision-making quality such as feeling the choice is informed, values based, and likely to be implemented as well as expressing satisfaction with the decision. 74-75 The DCS is comprised of items with response options ranging from 1 (strongly disagree) to 5 (strongly agree). The items are summed to total scale score with lower scores reflective of higher decision conflict and higher scores reflective of lower decision conflict.
Other Name: DCS

Behavioral: Shared Decision Making Questionnaire - Patient
Shared Decision Making Process will be measured from the patient perspective using the 9-item Shared Decision Making Questionnaire (SDM-Q-9),77 which has been validated with a Cronbach"s alpha of 0.94.
Other Name: SDM-Q-9

Behavioral: Stage of Readiness for Smoking Cessation - Contemplation Ladder
Among current smokers




Primary Outcome Measures :
  1. Key components of Shared Decision Making process that predict patient-perceived lung cancer screening decision quality [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All recruitment will take place at Kaiser Permanente Washington.
Criteria

Inclusion Criteria:

CLINICIANS:

  • Clinician (physician, nurse practitioner, or physician assistant)
  • Practicing in a KPWA primary care clinic
  • Having a patient panel with >/= 10 lung cancer screening eligible patients

PATIENTS (Quantitative Phase):

  • Age 55-80 years
  • >/= 30 pack-year tobacco smoking history
  • Current smoker or former smoker who has quit within the past 15 years
  • Documented SDM lung cancer screening discussion during a recent clinic visit

PATIENTS (Qualitative Phase)

  • Age 55-80 years
  • >/= 30 pack-year tobacco smoking history
  • Current smoker or former smoker who has quit within the past 15 years

Exclusion Criteria:

PATIENTS:

  • Significant comorbidities (Charlson Comorbidity Index >/=3)
  • Lung cancer diagnosis

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): NCT03891602


Contacts
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Contact: Lisa Carter-Harris, PhD 646-888-0040 carterl@mskcc.org
Contact: Jamie Ostroff, PhD 646-888-0041 ostroffj@mskcc.org

Locations
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United States, Washington
Kaiser Permanente Washington Health Research Institute Recruiting
Seattle, Washington, United States, 98101-1466
Contact: Diana Buist, PhD, MPH    206-287-2931    Diana.S.Buist@kp.org   
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Indiana University
Kaiser Permanente
University of North Carolina
Investigators
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Principal Investigator: Lisa Carter-Harris, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03891602    
Other Study ID Numbers: 19-007
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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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 Memorial Sloan Kettering Cancer Center:
Smoker
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases