DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement

NCT ID: NCT03891602

Last Updated: 2024-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

654 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-22

Study Completion Date

2023-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Smoking, Tobacco Smoking, Cigarette Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinicians

Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients

Primary Care Clinicians' Lung Cancer Screening Survey

Intervention Type BEHAVIORAL

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

Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Shared Decision Making Questionnaire (SDM-Q)- Patient

Intervention Type 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.

Stage of Readiness for Smoking Cessation - Contemplation Ladder

Intervention Type BEHAVIORAL

Among current smokers

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Stage of Readiness for Smoking Cessation - Contemplation Ladder

Among current smokers

Intervention Type BEHAVIORAL

Primary Care Clinicians' Lung Cancer Screening Survey

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

Intervention Type BEHAVIORAL

Other Intervention Names

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DCS SDM-Q-9

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Hackensack Meridian Health

OTHER

Sponsor Role lead

Responsible Party

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Lisa Carter-Bawa, PhD

Director | Cancer Prevention Precision Control Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamie Ostroff, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Lisa Carter-Bawa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

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Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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Pro2022-0776

Identifier Type: OTHER

Identifier Source: secondary_id

19-007

Identifier Type: -

Identifier Source: org_study_id

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