DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement
DECIDE
Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening
2 other identifiers
observational
654
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2019
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedResults Posted
Study results publicly available
August 23, 2024
CompletedAugust 23, 2024
August 1, 2024
3.8 years
March 25, 2019
June 26, 2024
August 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Clinicians
Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients
Smokers/Former Smokers
Current smoker or former smoker who has quit within the past 15 years
Interventions
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.
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.
Eligibility Criteria
All recruitment will take place at Kaiser Permanente Washington.
You may qualify if:
- 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
You may not qualify if:
- PATIENTS:
- Significant comorbidities (Charlson Comorbidity Index \>/=3)
- Lung cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hackensack Meridian Healthlead
- National Cancer Institute (NCI)collaborator
- Indiana Universitycollaborator
- University of North Carolinacollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- Kaiser Permanentecollaborator
Study Sites (1)
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Carter-Bawa, PhD, MPH, APRN, ANP-C, FAAN
- Organization
- Hackensack Meridian Health
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Ostroff, PhD
Memorial Sloan Kettering Cancer Center
- PRINCIPAL INVESTIGATOR
Lisa Carter-Bawa, PhD
Hackensack Meridian Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director | Cancer Prevention Precision Control Institute
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 27, 2019
Study Start
March 22, 2019
Primary Completion
January 10, 2023
Study Completion
January 10, 2023
Last Updated
August 23, 2024
Results First Posted
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
• 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.