Lung CancerNCT05456841
Empathic Communication Skills (ECS) Training
A study testing Empathic Communication Skills (ECS) training in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial summary
Research indicates that perceived stigma within medical encounters is prevalent and problematic for lung cancer patients' well-being and quality of cancer care. Promoting empathic communication appears to be a potentially effective intervention target to help reduce patients' perceptions of stigma within clinical… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Empathic Communication Skills (ECS) training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,232 participants
- Where
- 12 sitesUnited States
- Study dates
- 28 Apr 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Site Eligibility
- 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;
Show all 20Show fewer
- 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
Who cannot join
- Patient Exclusion
- Individuals of impaired decision-making capacity as per a clinician's judgment or as documented in the EMR.
- Site and OCP Exclusion
- None
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 8 recruiting
- Recruiting
Roswell Park Cancer Institute (Data Collection Only)
Buffalo, New York, 14263-0001
Elisabeth Dexter, MD, 716-845-2300
- Recruiting
Chesapeake Regional Healthcare (Data Collection Only)
Chesapeake, Virginia, 23320
Stephen Noble, MD, 757-842-4499
- Recruiting
Hackensack Meridian Health (Data collection only)
Hackensack, New Jersey, 07601
David Greenberg, MD, 551-996-8704
- Completed
Providence St. Joseph Health (Data Collection Only)
Irvine, California, 92612
- Completed
University of Kentucky (Data Collection Only)
Lexington, Kentucky, 40536-0093
- Recruiting
Advocate Health Care Network
Libertyville, Illinois, 60048
Michael Breen, MD, 847-367-6781
- Recruiting
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, 33143
Ian Bostock, MD, 786-596-2000
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Smita Banerjee, PhD, 646-888-0011
- Completed
Virtua Health (Data Collection Only)
Philadelphia, Pennsylvania, 08060
- Recruiting
University of Pennsylvania (Data Collection Only)
Philadelphia, Pennsylvania, 19104-4283
Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP, (215) 615-5858
- Recruiting
Fox Chase Cancer Center (Data Collection Only)
Philadelphia, Pennsylvania, 19111
Linda Fleisher, PhD, MPH, 215-728-4066
- Completed
Munson Healthcare (Data Collection Only)
Traverse City, Michigan, 49684
About this study
Official title: Empathic Communication Skills Training to Reduce Lung Cancer Stigma
Research indicates that perceived stigma within medical encounters is prevalent and problematic for lung cancer patients' well-being and quality of cancer care. Promoting empathic communication appears to be a potentially effective intervention target to help reduce patients' perceptions of stigma within clinical encounters; however, no formal trainings exist that focus on teaching empathic communication to oncology care providers (OCPs). Building upon favorable findings from a prior R21 (R21CA202793) and the importance of developing interventions to address lung cancer stigma, our goal is to conduct a national trial of empathic communication skills (ECS) training to facilitate improvements in the medical and psychosocial care of patients through de-stigmatizing interactions with OCPs for patients diagnosed with lung cancer.
Read the detailed description
The aims of this study are:
- 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);
- 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
- 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
- Lung Cancer
- Being tested
- Empathic Communication Skills (ECS) training, Standard of Care participant interaction
- Keywords
- lung cancer, thoracic oncology physician, thoracic oncology nurse practitioner, thoracic oncology physicians assistant, 21-339, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empathic Communication Skills (ECS) trainingBehavioural
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 interactionOther
Standard of Care participant interaction
| Study group | Role | What they receive |
|---|---|---|
| Oncology Care Providers/OCP-intervention group | Experimental | Providers participate in Empathic Communication Skills (ECS) training Receives: Behavioral: Empathic Communication Skills (ECS) training |
| Oncology Care Providers/OCP-control group | Active comparator | Providers complete all study measures and are offered ECS training after data collection is completed at their site. Receives: Other: Standard of Care participant interaction |
| Participants with Lung Cancer-intervention group | Experimental | Participants will engage with oncology care providers/OCP who have undergone Empathic Communication Skills (ECS) training Receives: Behavioral: Empathic Communication Skills (ECS) training |
| Participants with Lung Cancer-control group | Active comparator | Waitlist control group - WLC Receives: Other: Standard of Care participant interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of communication skills using standardized patient assessment/SPAs
A SPA involves a 12-minute video recorded interaction between the Oncology Care Provider/OCP and the Standardized Patient/SP on a given clinical scenario, using standardized scripts by the SP. Each OCP will participate in one SPA prior to their ECS training and one SPA following training or the timed control period. In contrast to clinical consultation recordings with varied clinical situations that do not necessitate the use of all strategies and skills, the semi-structured nature of SPAs permits appraisal of all desired elements of training.
Measured: 3 months
Uptake of empathy skills using standardized patient assessment/SPAs
A SPA involves a 12-minute video recorded interaction between the Oncology Care Provider/OCP and the Standardized Patient/SP on a given clinical scenario, using standardized scripts by the SP. Each OCP will participate in one SPA prior to their ECS training and one SPA following training or the timed control period. In contrast to clinical consultation recordings with varied clinical situations that do not necessitate the use of all strategies and skills, the semi-structured nature of SPAs permits appraisal of all desired elements of training.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start28 Apr 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Go2 Foundation for Lung Cancer
- Responsible party
- Sponsor
- Investigators
- Smita Banerjee, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456841
- Sponsor's protocol ID
- 21-339
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- 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.
Publications
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.
PubMed 39182827Banerjee 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.
PubMed 37579304
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathic Communication Skills Training to Reduce Lung Cancer Stigma
- ClinicalTrials.gov ID
- NCT05456841
- Acronym / sponsor ID
- 21-339
- Conditions
- Lung Cancer
- Keywords
- lung cancer, thoracic oncology physician, thoracic oncology nurse practitioner, thoracic oncology physicians assistant, 21-339, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,232 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Go2 Foundation for Lung Cancer
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research indicates that perceived stigma within medical encounters is prevalent and problematic for lung cancer patients' well-being and quality of cancer care. Promoting empathic communication appears to be a potentially effective intervention target to help reduce patients' perceptions of stigma within clinical encounters; however, no formal trainings exist that focus on teaching empathic communication to oncology care providers (OCPs). Building upon favorable findings from a prior R21 (R21CA202793) and the importance of developing interventions to address lung cancer stigma, our goal is to conduct a national trial of empathic communication skills (ECS) training to facilitate improvements in the medical and psychosocial care of patients through de-stigmatizing interactions with OCPs for patients diagnosed with lung cancer.
Detailed description
The aims of this study are:
- 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);
- 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
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oncology Care Providers/OCP-intervention group | Experimental | Behavioral: Empathic Communication Skills (ECS) trainingProviders participate in Empathic Communication Skills (ECS) training |
| Oncology Care Providers/OCP-control group | Active comparator | Other: Standard of Care participant interactionProviders complete all study measures and are offered ECS training after data collection is completed at their site. |
| Participants with Lung Cancer-intervention group | Experimental | Behavioral: Empathic Communication Skills (ECS) trainingParticipants will engage with oncology care providers/OCP who have undergone Empathic Communication Skills (ECS) training |
| Participants with Lung Cancer-control group | Active comparator | Other: Standard of Care participant interactionWaitlist control group - WLC |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Site Eligibility
- 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;
Key exclusion criteria (4 listed)
- Patient Exclusion
- Individuals of impaired decision-making capacity as per a clinician's judgment or as documented in the EMR.
- Site and OCP Exclusion
- None
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 |
|---|---|---|
| Empathic Communication Skills (ECS) trainingThe 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 | Behavioural | Oncology Care Providers/OCP-intervention group, Participants with Lung Cancer-intervention group |
| Standard of Care participant interactionStandard of Care participant interaction | Other | Oncology Care Providers/OCP-control group, Participants with Lung Cancer-control group |
Primary outcome
Uptake of communication skills using standardized patient assessment/SPAs
Time frame: 3 months
A SPA involves a 12-minute video recorded interaction between the Oncology Care Provider/OCP and the Standardized Patient/SP on a given clinical scenario, using standardized scripts by the SP. Each OCP will participate in one SPA prior to their ECS training and one SPA following training or the timed control period. In contrast to clinical consultation recordings with varied clinical situations that do not necessitate the use of all strategies and skills, the semi-structured nature of SPAs permits appraisal of all desired elements of training.
Uptake of empathy skills using standardized patient assessment/SPAs
Time frame: 3 months
A SPA involves a 12-minute video recorded interaction between the Oncology Care Provider/OCP and the Standardized Patient/SP on a given clinical scenario, using standardized scripts by the SP. Each OCP will participate in one SPA prior to their ECS training and one SPA following training or the timed control period. In contrast to clinical consultation recordings with varied clinical situations that do not necessitate the use of all strategies and skills, the semi-structured nature of SPAs permits appraisal of all desired elements of training.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 39182827Banerjee 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.
- Derived from this study: PubMed 37579304Banerjee 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.
- 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.
Smita Banerjee, PhD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empathic Communication Skills (ECS) training in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites 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 20 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smita Banerjee, PhD (646-888-0011, banerjes@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of communication skills using standardized patient assessment/SPAs (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456841, which also lists 2 linked publications.
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 7 Oct 2026.