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RecruitingNCT05456841Updated Oct 7, 2026

Empathic Communication Skills (ECS) Training

An interventional study of Empathic Communication Skills (ECS) training and Standard of Care participant interaction in Lung Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 12 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 5 months later.
Updated Oct 1, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,232
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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:

  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.

02

Conditions studied

  • Lung Cancer

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Keywords

  • lung cancer
  • thoracic oncology physician
  • thoracic oncology nurse practitioner
  • thoracic oncology physicians assistant
  • 21-339
  • Memorial Sloan Kettering Cancer Center
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 1,232 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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;
  • 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

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
1,232 participants (estimated)

Study arms

  • Experimental
    Oncology Care Providers/OCP-intervention group

    Providers participate in Empathic Communication Skills (ECS) training

    Behavioral: Empathic Communication Skills (ECS) training

  • Active comparator
    Oncology Care Providers/OCP-control group

    Providers complete all study measures and are offered ECS training after data collection is completed at their site.

    Other: Standard of Care participant interaction

  • Experimental
    Participants with Lung Cancer-intervention group

    Participants will engage with oncology care providers/OCP who have undergone Empathic Communication Skills (ECS) training

    Behavioral: Empathic Communication Skills (ECS) training

  • Active comparator
    Participants with Lung Cancer-control group

    Waitlist control group - WLC

    Other: Standard of Care participant interaction

Interventions

  • BehavioralEmpathic 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

  • OtherStandard of Care participant interaction

    Standard of Care participant interaction

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

07

Study locations

8 of 12 sites recruiting
  • Providence St. Joseph Health (Data Collection Only)
    Irvine, California 92612, United States
    Completed
  • BAPTIST ALLIANCE - MCI (Data Collection Only)
    Miami, Florida 33143, United States
    • Ian Bostock, MD · Contact · 786-596-2000
    Recruiting
  • Advocate Health Care Network
    Libertyville, Illinois 60048, United States
    • Michael Breen, MD · Contact · 847-367-6781
    Recruiting
  • University of Kentucky (Data Collection Only)
    Lexington, Kentucky 40536-0093, United States
    Completed
  • Munson Healthcare (Data Collection Only)
    Traverse City, Michigan 49684, United States
    Completed
  • Hackensack Meridian Health (Data collection only)
    Hackensack, New Jersey 07601, United States
    • David Greenberg, MD · Contact · 551-996-8704
    Recruiting
  • Roswell Park Cancer Institute (Data Collection Only)
    Buffalo, New York 14263-0001, United States
    • Elisabeth Dexter, MD · Contact · 716-845-2300
    Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    • Smita Banerjee, PhD · Contact · 646-888-0011
    Recruiting
  • Virtua Health (Data Collection Only)
    Philadelphia, Pennsylvania 08060, United States
    Completed
  • University of Pennsylvania (Data Collection Only)
    Philadelphia, Pennsylvania 19104-4283, United States
    • Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP · Contact · (215) 615-5858
    Recruiting
  • Fox Chase Cancer Center (Data Collection Only)
    Philadelphia, Pennsylvania 19111, United States
    • Linda Fleisher, PhD, MPH · Contact · 215-728-4066
    Recruiting
  • Chesapeake Regional Healthcare (Data Collection Only)
    Chesapeake, Virginia 23320, United States
    • Stephen Noble, MD · Contact · 757-842-4499
    Recruiting
08

References and documents

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 39182827 ↗
  • 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. PubMed 37579304 ↗

Individual participant data

Plan to share: 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.

09

Updates

2 registry updates since Sep 25, 2026
Primary completion
Aug 31, 2026→Aug 31, 2027
Oct 1, 2026
Study completion
Aug 31, 2026→Aug 31, 2027
Oct 1, 2026
Show all 2 updates
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 1, 2026
    Primary completion Aug 31, 2026→Aug 31, 2027
    Study completion Aug 31, 2026→Aug 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05456841
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc., Go2 Foundation for Lung Cancer
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Apr 28, 2023
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Smita Banerjee, PhD
Contact
banerjes@mskcc.org
646-888-0011
Jamie Ostroff, PhD
Contact
ostroffj@mskcc.org
646-888-0041
Smita Banerjee, PhD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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