Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1232 participants
INTERVENTIONAL
2023-04-28
2026-08-31
Brief Summary
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Detailed Description
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1. to evaluate the effect of the ECS training on OCP primary outcomes (communication and empathic skill uptake) and secondary outcomes (ECS training appraisal - relevance, novelty, clarity; self-efficacy, empathy, compassion burn-out);
2. to evaluate the effect of the ECS training vs. WLC on patients' reported primary outcomes (lung cancer stigma), and secondary outcomes (perceived clinician empathy, satisfaction with communication, psychological distress, patients' experience of clinical encounter, and overall patient satisfaction).
Additionally, acceptance of referral to tobacco cessation (for those currently smoking) will be explored; and
3. to examine potential moderators of OCP (e.g., demographic characteristics, professional role characteristics) and patient outcomes (e.g., demographic characteristics, illness characteristics).
Our central hypothesis is that the ECS training will demonstrate significant short-term improvements in clinicians' uptake of empathic skills and self-efficacy and will be superior to WLC with regards to patient reported measures of stigma, clinician empathy, satisfaction, and overall experience.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Oncology Care Providers/OCP-intervention group
Providers participate in Empathic Communication Skills (ECS) training
Empathic Communication Skills (ECS) training
The overall training goal of this 2.25 hour module ECS module is to enhance OCP recognition and responsiveness to lung cancer patients' empathic opportunities by communicating understanding, alleviating stigma and distress, and providing support. The ECS training also provides tools to OCPs to buffer/inoculate patients against stigmatizing attitudes and behaviors by others such that lung cancer patients who currently or formerly smoked can be given "small doses" of an opposing viewpoint (termed as "preparing patients for recurring smoking questions") and suggestions of "counterarguments" in order to make them resistant to future stigmatizing attacks by others
Oncology Care Providers/OCP-control group
Providers complete all study measures and are offered ECS training after data collection is completed at their site.
Standard of Care participant interaction
Standard of Care participant interaction
Participants with Lung Cancer-intervention group
Participants will engage with oncology care providers/OCP who have undergone Empathic Communication Skills (ECS) training
Empathic Communication Skills (ECS) training
The overall training goal of this 2.25 hour module ECS module is to enhance OCP recognition and responsiveness to lung cancer patients' empathic opportunities by communicating understanding, alleviating stigma and distress, and providing support. The ECS training also provides tools to OCPs to buffer/inoculate patients against stigmatizing attitudes and behaviors by others such that lung cancer patients who currently or formerly smoked can be given "small doses" of an opposing viewpoint (termed as "preparing patients for recurring smoking questions") and suggestions of "counterarguments" in order to make them resistant to future stigmatizing attacks by others
Participants with Lung Cancer-control group
Waitlist control group - WLC
Standard of Care participant interaction
Standard of Care participant interaction
Interventions
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Empathic Communication Skills (ECS) training
The overall training goal of this 2.25 hour module ECS module is to enhance OCP recognition and responsiveness to lung cancer patients' empathic opportunities by communicating understanding, alleviating stigma and distress, and providing support. The ECS training also provides tools to OCPs to buffer/inoculate patients against stigmatizing attitudes and behaviors by others such that lung cancer patients who currently or formerly smoked can be given "small doses" of an opposing viewpoint (termed as "preparing patients for recurring smoking questions") and suggestions of "counterarguments" in order to make them resistant to future stigmatizing attacks by others
Standard of Care participant interaction
Standard of Care participant interaction
Eligibility Criteria
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Inclusion Criteria
* Employs at least 15 FTE OCPs (i.e., oncologists, nurse practitioners and physician assistants) as per self report
* Reports a clinic volume of at least 20 new lung cancer patients per month as per self report
OCP Participant Eligibility
* OCPs who are thoracic oncology physicians (radiologists, medical oncologists, pulmonologists, and surgeons), NPs, or PAs and currently treating lung cancer patients, as per self-report;
* OCP conducts consultations with lung cancer patients, as per self-report;
* OCP sees at least 1 lung cancer patient per week, as per self-report;
Patient Eligibility
* Patient under the care of a participating OCP as per self report;
* English and/or Spanish speaking;
* In general, which language do you prefer to receive your medical care, English/Spanish/both English and Spanish Equally?
* If English, treat as fluent in English, no additional language questions
* If Spanish, treat as fluent in Spanish, no additional language questions
* If both English and Spanish equally, ask the follow-up questions and go with whichever language is endorsed as best. If endorsed equally, assign to category patient prefers
* How well do you speak English? Not at all/ Not well/Well/Very well
* How well do you speak Spanish? Not at all/Not well/Well/Very well
* Is at least 18 years of age as per self report;
* Has a history of suspicious lung mass or confirmed lung cancer diagnosis, as per clinician judgment or medical record note;
* Is a former or current smoking as per self report;
* Has had no more than 10 prior visits with the participating OCP, as per the medical record and/or self report
Exclusion Criteria
* Individuals of impaired decision-making capacity as per a clinician's judgment or as documented in the EMR.
Site and OCP Exclusion
* None
18 Years
100 Years
ALL
Yes
Sponsors
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American Cancer Society, Inc.
OTHER
Go2 Foundation for Lung Cancer
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Smita Banerjee, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Providence St. Joseph Health (Data Collection Only)
Irvine, California, United States
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States
Advocate Health Care Network
Libertyville, Illinois, United States
University of Kentucky (Data Collection Only)
Lexington, Kentucky, United States
Munson Healthcare (Data Collection Only)
Traverse City, Michigan, United States
Hackensack Meridian Health (Data collection only)
Hackensack, New Jersey, United States
Roswell Park Cancer Institute (Data Collection Only)
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Virtua Health (Data Collection Only)
Philadelphia, Pennsylvania, United States
University of Pennsylvania (Data Collection Only)
Philadelphia, Pennsylvania, United States
Chesapeake Regional Healthcare (Data Collection Only)
Chesapeake, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Ian Bostock, MD
Role: primary
Michael Breen, MD
Role: primary
David Greenberg, MD
Role: primary
Elisabeth Dexter, MD
Role: primary
Smita Banerjee, PhD
Role: primary
Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP
Role: primary
Stephen Noble, MD
Role: primary
References
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Banerjee SC, Malling CD, Schofield EA, Carter-Bawa L, Bylund CL, Hamann HA, Parker PA, Shen MJ, Studts JL, Williamson TJ, Ostroff JS. Empathic communication skills training to reduce lung cancer stigma: Study protocol of a cluster randomized control trial. Contemp Clin Trials. 2024 Oct;145:107669. doi: 10.1016/j.cct.2024.107669. Epub 2024 Aug 23.
Banerjee SC, Malling CD, Shen MJ, Williamson TJ, Bylund CL, Studts JL, Mullett T, Carter-Bawa L, Hamann HA, Parker PA, Steliga M, Feldman J, Pantelas J, Borondy-Kitts A, Rigney M, King JC, Fathi JT, Rosenthal LS, Smith RA, Ostroff JS. Getting ready for prime time: Recommended adaptations of an Empathic Communication Skills training intervention to reduce lung cancer stigma for a national multi-center trial. Transl Behav Med. 2023 Sep 28;13(10):804-808. doi: 10.1093/tbm/ibad048.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-339
Identifier Type: -
Identifier Source: org_study_id
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