DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement (DECIDE)
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|ClinicalTrials.gov Identifier: NCT03891602|
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : July 30, 2020
|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|
|Study Type :||Observational|
|Estimated Enrollment :||625 participants|
|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|
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.
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
- Key components of Shared Decision Making process that predict patient-perceived lung cancer screening decision quality [ Time Frame: up to 12 months ]
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
|Contact: Lisa Carter-Harris, PhDfirstname.lastname@example.org|
|Contact: Jamie Ostroff, PhDemail@example.com|
|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|
|Principal Investigator:||Lisa Carter-Harris, PhD||Memorial Sloan Kettering Cancer Center|