SmokingDECIDENCT03891602
DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement
An observational study of Smoking and Smoking, Tobacco, run by Hackensack Meridian Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking, Tobacco, Smoking, Cigarette
- What is being tested?
- Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale), Patient Trust in the Medical and Decision Conflict Scale (DCS) - Lung Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 654 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 10 Jan 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All recruitment will take place at Kaiser Permanente Washington.
Who may be able to join
- 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
Show all 9Show fewer
- >/= 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
Who cannot join
- PATIENTS:
- Significant comorbidities (Charlson Comorbidity Index >/=3)
- Lung cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466
About this study
Official title: Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening
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.
- Conditions
- Smoking, Smoking, Tobacco, Smoking, Cigarette, Lung Cancer
- Being tested
- Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale), Patient Trust in the Medical, Decision Conflict Scale (DCS) - Lung Cancer Screening, Shared Decision Making Questionnaire (SDM-Q)- Patient, Stage of Readiness for Smoking Cessation - Contemplation Ladder
- Keywords
- Smoker, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Smoking, Tobacco Smoking, Cigarette Smoking, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)Behavioural
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 MedicalBehavioural
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 ScreeningBehavioural
Also called DCS
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)- PatientBehavioural
Also called SDM-Q-9
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 LadderBehavioural
Among current smokers
Primary Care Clinicians' Lung Cancer Screening SurveyBehavioural
Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians | Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients Receives: Behavioral: Primary Care Clinicians' Lung Cancer Screening Survey | |
| Smokers/Former Smokers | Current smoker or former smoker who has quit within the past 15 years Receives: Behavioral: Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale); Behavioral: Patient Trust in the Medical; Behavioral: Decision Conflict Scale (DCS) - Lung Cancer Screening; Behavioral: Shared Decision Making Questionnaire (SDM-Q)- Patient; Behavioral: Stage of Readiness for Smoking Cessation - Contemplation Ladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline (study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start22 Mar 2019
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Indiana University, University of North Carolina, Memorial Sloan Kettering Cancer Center, Kaiser Permanente
- Responsible party
- Principal investigator, Lisa Carter-Bawa, PhD, Hackensack Meridian Health
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer CenterLisa Carter-Bawa, PhD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891602
- Sponsor's protocol ID
- 19-007
- Other IDs
- Pro2022-0776
- Acronym
- DECIDE
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2019
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT03891602
- Acronym / sponsor ID
- DECIDE / 19-007
- Conditions
- Smoking, Smoking, Tobacco, Smoking, Cigarette, Lung Cancer
- Keywords
- Smoker, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Indiana University, University of North Carolina, Memorial Sloan Kettering Cancer Center, Kaiser Permanente
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinicians | – | Behavioral: Primary Care Clinicians' Lung Cancer Screening SurveyPrimary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients |
| Smokers/Former Smokers | – | Behavioral: Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale), Behavioral: Patient Trust in the Medical, Behavioral: Decision Conflict Scale (DCS) - Lung Cancer Screening, Behavioral: Shared Decision Making Questionnaire (SDM-Q)- Patient, Behavioral: Stage of Readiness for Smoking Cessation - Contemplation LadderCurrent smoker or former smoker who has quit within the past 15 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All recruitment will take place at Kaiser Permanente Washington.
Key inclusion criteria (9 listed)
- 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
- Age 55-80 years
- >/= 30 pack-year tobacco smoking history
Key exclusion criteria (3 listed)
- Significant comorbidities (Charlson Comorbidity Index >/=3)
- Lung cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Smokers/Former Smokers |
| Patient Trust in the MedicalMedical 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. | Behavioural | Smokers/Former Smokers |
| Decision Conflict Scale (DCS) - Lung Cancer ScreeningAlso: DCSThe 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. | Behavioural | Smokers/Former Smokers |
| Shared Decision Making Questionnaire (SDM-Q)- PatientAlso: SDM-Q-9Shared 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. | Behavioural | Smokers/Former Smokers |
| Stage of Readiness for Smoking Cessation - Contemplation LadderAmong current smokers | Behavioural | Smokers/Former Smokers |
| Primary Care Clinicians' Lung Cancer Screening SurveyIncludes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines. | Behavioural | Clinicians |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering Cancer Center
Lisa Carter-Bawa, PhD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking, Tobacco, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality (time frame: at baseline (study enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.