Lung Cancer, Smoking, Smoking, Cigarette, Smoking, Tobacco
Conditions
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
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 Cronbachs 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 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.
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.
Among current smokers
Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.
Sponsors
Study design
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
Exclusion criteria
PATIENTS: * Significant comorbidities (Charlson Comorbidity Index \>/=3) * Lung cancer diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 654 |
Baseline characteristics
| Characteristic | Smokers/Former Smokers | Total | Clinicians |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 5.9 | 66.4 years STANDARD_DEVIATION 5.9 | — |
| Age, Customized ≥ 18 and ≤ 50 years | 0 Participants | 80 Participants | 80 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized > 50 years | 529 Participants | 574 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 17 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 517 Participants | 637 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 44 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 16 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 30 Participants | 13 Participants |
| Race (NIH/OMB) White | 463 Participants | 542 Participants | 79 Participants |
| Region of Enrollment United States | 529 participants | 654 participants | 125 participants |
| Sex/Gender, Customized Female | 235 Participants | 316 Participants | 81 Participants |
| Sex/Gender, Customized Male | 294 Participants | 337 Participants | 43 Participants |
| Sex/Gender, Customized Prefer not to say | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 529 |
| other Total, other adverse events | 0 / 125 | 0 / 529 |
| serious Total, serious adverse events | 0 / 125 | 0 / 529 |
Outcome results
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smokers/Former Smokers | Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality | 21.5 score on a scale | Standard Deviation 15.5 |