Empathic Communication Skills (ECS) Training

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Empathic Communication Skills (ECS) training; Other: Standard of Care participant interaction

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.

• Study Type: Interventional
• Enrollment (Estimated): 1232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie Ostroff, PhD; Phone Number: 646-888-0041; Email: ostroffj@mskcc.org
• Study Contact Backup: Name: Smita Banerjee, PhD; Phone Number: 646-888-0011; Email: banerjes@mskcc.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

The site research staff will screen and identify eligible OCPs at their sites and inform their research colleagues at the Go2 Foundation for Lung Cancer and ACS who will then send an email to the OCPs describing the study and inviting participation. OCPs will be asked to reply to this email if they are interested in participating. The research staff at Go2 and ACS will communicate back to the site staff who is interested in order that the site staff can have follow-up phone/email discussions with the OCPs that will encompass a thorough description of the study procedures, OCP involvement, and getting a verbal informed consent from interested OCP participants.

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oncology Care Providers/OCP-intervention group; Providers participate in Empathic Communication Skills (ECS) training	Behavioral: 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
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; 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; 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
Active Comparator: Participants with Lung Cancer-control group; Waitlist control group - WLC	Other: Standard of Care participant interaction; Standard of Care participant interaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: American Cancer Society, Inc.; Go2 Foundation for Lung Cancer
• Investigators: Principal Investigator: Smita Banerjee, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General 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.
• 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.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: lung cancer; Memorial Sloan Kettering Cancer Center; thoracic oncology physician; thoracic oncology nurse practitioner; thoracic oncology physicians assistant; 21-339
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 21-339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No