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DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03891602
Acronym
DECIDE
Enrollment
654
Registered
2019-03-27
Start date
2019-03-22
Completion date
2023-01-10
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Smoking, Smoking, Cigarette, Smoking, Tobacco

Keywords

Smoker, Memorial Sloan Kettering Cancer Center

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.

Interventions

BEHAVIORALCataldo 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.

BEHAVIORALPatient 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 Cronbachs alpha of 0.84.

BEHAVIORALDecision 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 OConnor,74-75 and validated in many health decisions including breast cancer screening with Cronbachs 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.

BEHAVIORALShared 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 Cronbachs alpha of 0.94.

BEHAVIORALStage of Readiness for Smoking Cessation - Contemplation Ladder

Among current smokers

BEHAVIORALPrimary Care Clinicians' Lung Cancer Screening Survey

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Indiana University
CollaboratorOTHER
University of North Carolina
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
CollaboratorOTHER
Kaiser Permanente
CollaboratorOTHER
Hackensack Meridian Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Qualityat 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Clinicians
Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients
125
Smokers/Former Smokers
Current smoker or former smoker who has quit within the past 15 years
529
Total654

Baseline characteristics

CharacteristicSmokers/Former SmokersTotalClinicians
Age, Continuous66.4 years
STANDARD_DEVIATION 5.9
66.4 years
STANDARD_DEVIATION 5.9
Age, Customized
≥ 18 and ≤ 50 years
0 Participants80 Participants80 Participants
Age, Customized
<18 years
0 Participants0 Participants0 Participants
Age, Customized
> 50 years
529 Participants574 Participants45 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants17 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
517 Participants637 Participants120 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Asian
23 Participants44 Participants21 Participants
Race (NIH/OMB)
Black or African American
14 Participants16 Participants2 Participants
Race (NIH/OMB)
More than one race
9 Participants16 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
17 Participants30 Participants13 Participants
Race (NIH/OMB)
White
463 Participants542 Participants79 Participants
Region of Enrollment
United States
529 participants654 participants125 participants
Sex/Gender, Customized
Female
235 Participants316 Participants81 Participants
Sex/Gender, Customized
Male
294 Participants337 Participants43 Participants
Sex/Gender, Customized
Prefer not to say
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1250 / 529
other
Total, other adverse events
0 / 1250 / 529
serious
Total, serious adverse events
0 / 1250 / 529

Outcome results

Primary

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.

Time frame: at baseline (study enrollment)

ArmMeasureValue (MEAN)Dispersion
Smokers/Former SmokersKey Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality21.5 score on a scaleStandard Deviation 15.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026