Clinical trial NCT05456841: Empathic Communication Skills (ECS) Training
Official title: Empathic Communication Skills Training to Reduce Lung Cancer Stigma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
thoracic oncology physician
thoracic oncology nurse practitioner
thoracic oncology physicians assistant
21-339
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Go2 Foundation for Lung Cancer
First posted: 2022-07-13
Enrollment: 1232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

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

Primary outcomes:
measure: Uptake of communication skills using standardized patient assessment/SPAs
timeFrame: 3 months
measure: Uptake of empathy skills using standardized patient assessment/SPAs
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Providence St. Joseph Health (Data Collection Only)
state: California
city: Libertyville
country: United States
facility: Advocate Health Care Network
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky (Data Collection Only)
state: Kentucky
city: Traverse City
country: United States
facility: Munson Healthcare (Data Collection Only)
state: Michigan
city: Hackensack
country: United States
facility: Hackensack Meridian Health (Data collection only)
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Philadelphia
country: United States
facility: Virtua Health (Data Collection Only)
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania (Data Collection Only)
state: Pennsylvania
city: Chesapeake
country: United States
facility: Chesapeake Regional Healthcare (Data Collection Only)
state: Virginia
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Smita Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
References: