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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Lung Cancer; Smoking, Tobacco; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Primary Care Clinicians' Lung Cancer Screening Survey; Behavioral: Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale); Behavioral: Patient Trust in the Medical; Behavioral: Stage of Readiness for Smoking Cessation - Contemplation Ladder; Behavioral: Decision Conflict Scale (DCS) - Lung Cancer Screening; Behavioral: Shared Decision Making Questionnaire (SDM-Q)- Patient

• Study Type: Observational
• Enrollment (Actual): 654

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101-1466
      • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All recruitment will take place at Kaiser Permanente Washington.

Description

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

Exclusion Criteria:

PATIENTS:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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: Stage of Readiness for Smoking Cessation - Contemplation Ladder; Among current smokers; Behavioral: Decision Conflict Scale (DCS) - 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 Names: DCS; Behavioral: Shared Decision Making Questionnaire (SDM-Q)- 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 Names: SDM-Q-9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: National Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center; Indiana University; Kaiser Permanente; University of North Carolina
• Investigators: Principal Investigator: Lisa Carter-Bawa, PhD, Hackensack Meridian Health; Principal Investigator: Jamie Ostroff, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Smoker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 19-007; Pro2022-0776 (Other Identifier: Hackensack Meridian Health IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No