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Completed

NCT Number: NCT03891602

DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement

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.

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Key information

Conditions

Smoking Behavior Cigarette Smoking Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking, Cigarette Smoking, Tobacco Thoracic Neoplasms Tobacco Smoking Tobacco Use

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101-1466, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)

Behavioral

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

Behavioral

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 (DCS) - Lung Cancer Screening

Behavioral

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

Shared Decision Making Questionnaire (SDM-Q)- Patient

Behavioral

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

Stage of Readiness for Smoking Cessation - Contemplation Ladder

Behavioral

Among current smokers

Primary Care Clinicians' Lung Cancer Screening Survey

Behavioral

Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.

Primary outcomes

  1. Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality

    Time frame: at baseline (study enrollment)

    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.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Indiana University
  • Kaiser Permanente
  • Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • University of North Carolina

Registry information

Official study title

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

Acronym: DECIDE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2019
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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