NCT05456841

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,232

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
4mo left

Started Apr 2023

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2023Aug 2026

First Submitted

Initial submission to the registry

July 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

July 8, 2022

Last Update Submit

March 16, 2026

Conditions

Keywords

lung cancerthoracic oncology physicianthoracic oncology nurse practitionerthoracic oncology physicians assistant21-339Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Oncology Care Providers/OCP-intervention group

EXPERIMENTAL

Providers participate in Empathic Communication Skills (ECS) training

Behavioral: Empathic Communication Skills (ECS) training

Oncology Care Providers/OCP-control group

ACTIVE COMPARATOR

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

Other: Standard of Care participant interaction

Participants with Lung Cancer-intervention group

EXPERIMENTAL

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

Behavioral: Empathic Communication Skills (ECS) training

Participants with Lung Cancer-control group

ACTIVE COMPARATOR

Waitlist control group - WLC

Other: Standard of Care participant interaction

Interventions

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

Oncology Care Providers/OCP-intervention groupParticipants with Lung Cancer-intervention group

Standard of Care participant interaction

Oncology Care Providers/OCP-control groupParticipants with Lung Cancer-control group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • Individuals of impaired decision-making capacity as per a clinician's judgment or as documented in the EMR.
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Providence St. Joseph Health (Data Collection Only)

Irvine, California, 92612, United States

COMPLETED

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, 33143, United States

RECRUITING

Advocate Health Care Network

Libertyville, Illinois, 60048, United States

RECRUITING

University of Kentucky (Data Collection Only)

Lexington, Kentucky, 40536-0093, United States

COMPLETED

Munson Healthcare (Data Collection Only)

Traverse City, Michigan, 49684, United States

COMPLETED

Hackensack Meridian Health (Data collection only)

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Park Cancer Institute (Data Collection Only)

Buffalo, New York, 14263-0001, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Virtua Health (Data Collection Only)

Philadelphia, Pennsylvania, 08060, United States

COMPLETED

University of Pennsylvania (Data Collection Only)

Philadelphia, Pennsylvania, 19104-4283, United States

RECRUITING

Fox Chase Cancer Center (Data Collection Only)

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Chesapeake Regional Healthcare (Data Collection Only)

Chesapeake, Virginia, 23320, United States

RECRUITING

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Smita Banerjee, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Smita Banerjee, PhD

CONTACT

Jamie Ostroff, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 13, 2022

Study Start

April 28, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Locations