Empathic Communication Skills (ECS) Training

Official title

Empathic Communication Skills Training to Reduce Lung Cancer Stigma

Overview

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:

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.

Interventions

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

Primary outcome measures

• Uptake of communication skills using standardized patient assessment/SPAs [Time frame: 3 months]
• Uptake of empathy skills using standardized patient assessment/SPAs [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 12 centers

• Providence St. Joseph Health (Data Collection Only) — Irvine
• BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami
• Advocate Health Care Network — Libertyville
• University of Kentucky (Data Collection Only) — Lexington
• Munson Healthcare (Data Collection Only) — Traverse City
• Hackensack Meridian Health (Data collection only) — Hackensack
• Roswell Park Cancer Institute (Data Collection Only) — Buffalo
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• … and 4 more centers

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. PMID 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-cen PMID 37579304

Identifiers

NCT: NCT05456841 · 21-339

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗