Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Go2 Foundation for Lung Cancer | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncology Care Providers/OCP-intervention group | Experimental | Providers participate in 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. |
|
| Participants with Lung Cancer-intervention group | Experimental | Participants will engage with oncology care providers/OCP who have undergone Empathic Communication Skills (ECS) training |
|
| Participants with Lung Cancer-control group | Active Comparator | Waitlist control group - WLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empathic Communication Skills (ECS) training | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Site Eligibility
OCP Participant Eligibility
Patient Eligibility
Patient under the care of a participating OCP as per self report;
English and/or Spanish speaking;
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
Site and OCP Exclusion
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Smita Banerjee, PhD | Contact | 646-888-0011 | banerjes@mskcc.org | |
| Jamie Ostroff, PhD | Contact | 646-888-0041 | ostroffj@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Smita Banerjee, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Joseph Health (Data Collection Only) | Completed | Irvine | California | 92612 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39182827 | Derived | 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. | |
| 37579304 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care participant interaction | Other | Standard of Care participant interaction |
|
| BAPTIST ALLIANCE - MCI (Data Collection Only) |
| Recruiting |
| Miami |
| Florida |
| 33143 |
| United States |
|
| Advocate Health Care Network | Recruiting | Libertyville | Illinois | 60048 | United States |
|
| University of Kentucky (Data Collection Only) | Completed | Lexington | Kentucky | 40536-0093 | United States |
| Munson Healthcare (Data Collection Only) | Completed | Traverse City | Michigan | 49684 | United States |
| Hackensack Meridian Health (Data collection only) | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Roswell Park Cancer Institute (Data Collection Only) | Recruiting | Buffalo | New York | 14263-0001 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Virtua Health (Data Collection Only) | Completed | Philadelphia | Pennsylvania | 08060 | United States |
| University of Pennsylvania (Data Collection Only) | Recruiting | Philadelphia | Pennsylvania | 19104-4283 | United States |
|
| Fox Chase Cancer Center (Data Collection Only) | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
|
| Chesapeake Regional Healthcare (Data Collection Only) | Recruiting | Chesapeake | Virginia | 23320 | United States |
|
| 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. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided