DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement

Lung Cancer Clinical Trial

— DECIDE  

Official title:

Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03891602
• Other study ID #: 19-007
• Status: Withdrawn
• Start date: March 22, 2019
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Smoking
• Smoking, Cigarette
• Smoking, Tobacco

Intervention

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.
• 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.
• 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.
• 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.
• Stage of Readiness for Smoking Cessation - Contemplation Ladder
Among current smokers
• Primary Care Clinicians' Lung Cancer Screening Survey
Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Indiana University, Kaiser Permanente, National Cancer Institute (NCI), University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Key components of Shared Decision Making process that predict patient-perceived lung cancer screening decision quality		up to 12 months

External Links

•   Memorial Sloan Kettering Cancer Center