Empathic Communication Skills (ECS) Training

Lung Cancer Clinical Trial

Official title:

Empathic Communication Skills Training to Reduce Lung Cancer Stigma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456841
• Other study ID #: 21-339
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Smita Banerjee, PhD
• Phone: 646-888-0011
• Email: banerjes[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1232
• Est. completion date: August 31, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Other:
• Standard of Care participant interaction
Standard of Care participant interaction

Locations

Country	Name	City	State
United States	Chesapeake Regional Healthcare (Data Collection Only)	Chesapeake	Virginia
United States	Hackensack Meridian Health (Data collection only)	Hackensack	New Jersey
United States	Providence St. Joseph Health (Data Collection Only)	Irvine	California
United States	University of Kentucky (Data Collection Only)	Lexington	Kentucky
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	Munson Healthcare (Data Collection Only)	Traverse City	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	American Cancer Society, Inc., Go2 Foundation for Lung Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center