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Empathic Communication Skills (ECS) Training

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empathic Communication Skills (ECS) training
Standard of Care participant interaction
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring lung cancer, thoracic oncology physician, thoracic oncology nurse practitioner, thoracic oncology physicians assistant, 21-339, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 clinic 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 suspicious lung mass or confirmed lung cancer diagnosis, as per clinician judgment or medical record note;
  • Is a former or current smoker as per self report;
  • Has had no more than 5 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

Sites / Locations

  • Providence St. Joseph Health (Data Collection Only)Recruiting
  • University of Kentucky (Data Collection Only)Recruiting
  • Munson Healthcare (Data Collection Only)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Virtua Health (Data Collection Only)Recruiting
  • Chesapeake Regional Healthcare (Data Collection Only)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Oncology Care Providers/OCP-intervention group

Oncology Care Providers/OCP-control group

Participants with Lung Cancer-intervention group

Participants with Lung Cancer-control group

Arm Description

Providers participate in Empathic Communication Skills (ECS) training

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

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

Waitlist control group - WLC

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2022
Last Updated
October 24, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc., Go2 Foundation for Lung Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT05456841
Brief Title
Empathic Communication Skills (ECS) Training
Official Title
Empathic Communication Skills Training to Reduce Lung Cancer Stigma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc., Go2 Foundation for Lung Cancer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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); 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, thoracic oncology physician, thoracic oncology nurse practitioner, thoracic oncology physicians assistant, 21-339, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncology Care Providers/OCP-intervention group
Arm Type
Experimental
Arm Description
Providers participate in Empathic Communication Skills (ECS) training
Arm Title
Oncology Care Providers/OCP-control group
Arm Type
Active Comparator
Arm Description
Providers complete all study measures and are offered ECS training after data collection is completed at their site.
Arm Title
Participants with Lung Cancer-intervention group
Arm Type
Experimental
Arm Description
Participants will engage with oncology care providers/OCP who have undergone Empathic Communication Skills (ECS) training
Arm Title
Participants with Lung Cancer-control group
Arm Type
Active Comparator
Arm Description
Waitlist control group - WLC
Intervention Type
Behavioral
Intervention Name(s)
Empathic Communication Skills (ECS) training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care participant interaction
Intervention Description
Standard of Care participant interaction
Primary Outcome Measure Information:
Title
Uptake of communication skills using standardized patient assessment/SPAs
Description
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
Title
Uptake of empathy skills using standardized patient assessment/SPAs
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Smita Banerjee, PhD
Phone
646-888-0011
Email
banerjes@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Ostroff, PhD
Phone
646-888-0041
Email
ostroffj@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smita Banerjee, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence St. Joseph Health (Data Collection Only)
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areo Saffarzadeh, MD
Phone
949-364-6264
Email
areo@octcs.com
Facility Name
University of Kentucky (Data Collection Only)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Burris, PhD
Phone
859-257-9612
Facility Name
Munson Healthcare (Data Collection Only)
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Worden, FNP
Phone
231-392-8400
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Smita Banerjee, PhD
Phone
646-888-0011
Facility Name
Virtua Health (Data Collection Only)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
08060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Puc, MD
Phone
856-355-7176
Facility Name
Chesapeake Regional Healthcare (Data Collection Only)
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Noble, MD
Phone
757-842-4499

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Empathic Communication Skills (ECS) Training

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