NCT03891602|CompletedResults
DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement
DECIDE
Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening
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Sponsor study identifier
Secondary identifiers
OTHER · Hackensack Meridian Health IRB
observational
654
1 country
1
Study Start
March 22, 2019
Actual (reported)Primary Completion
January 10, 2023
Actual (reported)Study Completion
January 10, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 10, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2019
Actual (reported)March 25, 2019
Actual (reported)March 27, 2019
Actual (reported)January 10, 2023
Actual (reported)January 10, 2023
Actual (reported)August 23, 2024
Actual (reported)Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality
Decisional Quality was measured using the multidimensional Decisional Conflict Scale, a 16-item Likert-response scale that was modified by the investigators for the lung cancer screening context. The total score ranging from 0 to 64. This total score is commonly transformed into a standardized score that falls within a 0 to 100 range. Decisional quality measured on this numeric scale from which lower scores represent lower decisional conflict and, therefore, higher decisional quality. Scores below 25 have been associated with low decisional conflict.
at baseline (study enrollment)
Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients
Current smoker or former smoker who has quit within the past 15 years
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.
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.
All recruitment will take place at Kaiser Permanente Washington.
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466, United States
Jamie Ostroff, PhD
Memorial Sloan Kettering Cancer Center
Lisa Carter-Bawa, PhD
Hackensack Meridian Health
654 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2019
First Posted
March 27, 2019
Study Start
March 22, 2019
Actual (reported)Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of 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.
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.
Among current smokers
Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 10, 2023
Actual (reported)Study Completion
January 10, 2023
Actual (reported)Last Updated
August 23, 2024
Results First Posted
August 23, 2024
Record last verified: 2024-08
• 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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