Empatikus kommunikációs készségek képzése rákgondozók számára, hogy segítsenek megállítani a tüdőrák megbélyegzését a betegeknél
Empatikus kommunikációs készségek képzése a tüdőrák megbélyegzésének csökkentésére
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Jamie Ostroff, PhD
- Telefonszám: 646-888-0041
- E-mail: ostroffj@mskcc.org
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Smita Banerjee, PhD
- Telefonszám: 646-888-0011
- E-mail: banerjes@mskcc.org
Tanulmányi helyek
-
-
California
-
Irvine, California, Egyesült Államok, 92612
- Befejezve
- Providence St. Joseph Health (Data Collection Only)
-
-
Florida
-
Miami, Florida, Egyesült Államok, 33143
- Toborzás
- BAPTIST ALLIANCE - MCI (Data Collection Only)
-
Kapcsolatba lépni:
- Ian Bostock, MD
- Telefonszám: 786-596-2000
-
-
Illinois
-
Libertyville, Illinois, Egyesült Államok, 60048
- Toborzás
- Advocate Health Care Network
-
Kapcsolatba lépni:
- Michael Breen, MD
- Telefonszám: 847-367-6781
-
-
Kentucky
-
Lexington, Kentucky, Egyesült Államok, 40536-0093
- Befejezve
- University of Kentucky (Data Collection Only)
-
-
Michigan
-
Traverse City, Michigan, Egyesült Államok, 49684
- Befejezve
- Munson Healthcare (Data Collection Only)
-
-
New Jersey
-
Hackensack, New Jersey, Egyesült Államok, 07601
- Toborzás
- Hackensack Meridian Health (Data collection only)
-
Kapcsolatba lépni:
- David Greenberg, MD
- Telefonszám: 551-996-8704
-
-
New York
-
Buffalo, New York, Egyesült Államok, 14263-0001
- Toborzás
- Roswell Park Cancer Institute (Data Collection Only)
-
Kapcsolatba lépni:
- Elisabeth Dexter, MD
- Telefonszám: 716-845-2300
-
New York, New York, Egyesült Államok, 10065
- Toborzás
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Kapcsolatba lépni:
- Smita Banerjee, PhD
- Telefonszám: 646-888-0011
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Egyesült Államok, 19111
- Toborzás
- Fox Chase Cancer Center (Data Collection Only)
-
Kapcsolatba lépni:
- Linda Fleisher, PhD, MPH
- Telefonszám: 215-728-4066
-
Philadelphia, Pennsylvania, Egyesült Államok, 19104-4283
- Toborzás
- University of Pennsylvania (Data Collection Only)
-
Kapcsolatba lépni:
- Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP
- Telefonszám: (215) 615-5858
-
Philadelphia, Pennsylvania, Egyesült Államok, 08060
- Befejezve
- Virtua Health (Data Collection Only)
-
-
Virginia
-
Chesapeake, Virginia, Egyesült Államok, 23320
- Toborzás
- Chesapeake Regional Healthcare (Data Collection Only)
-
Kapcsolatba lépni:
- Stephen Noble, MD
- Telefonszám: 757-842-4499
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Oncology Care Providers/OCP-intervention group
Providers participate in 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 as "preparing patients for recurring smoking questions") and suggestions of "counterarguments" in order to make them resistant to future stigmatizing attacks by others |
|
Aktív összehasonlító: Oncology Care Providers/OCP-control group
Providers complete all study measures and are offered ECS training after data collection is completed at their site. |
Standard of Care participant interaction |
|
Kísérleti: Participants with Lung Cancer-intervention group
Participants will engage with oncology care providers/OCP who have undergone 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 as "preparing patients for recurring smoking questions") and suggestions of "counterarguments" in order to make them resistant to future stigmatizing attacks by others |
|
Aktív összehasonlító: Participants with Lung Cancer-control group
Waitlist control group - WLC |
Standard of Care participant interaction |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Uptake of communication skills using standardized patient assessment/SPAs
Időkeret: 3 months
|
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
Időkeret: 3 months
|
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
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Smita Banerjee, PhD, Memorial Sloan Kettering Cancer Center
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 21-339
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .