Opplæring i empatiske kommunikasjonsferdigheter for krefttilbydere for å stoppe lungekreftstigma som pasienter opplever
Opplæring i empatiske kommunikasjonsferdigheter for å redusere lungekreftstigma
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aims of this study are:
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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);
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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
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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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jamie Ostroff, PhD
- Telefonnummer: 646-888-0041
- E-post: ostroffj@mskcc.org
Studer Kontakt Backup
- Navn: Smita Banerjee, PhD
- Telefonnummer: 646-888-0011
- E-post: banerjes@mskcc.org
Studiesteder
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California
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Irvine, California, Forente stater, 92612
- Fullført
- Providence St. Joseph Health (Data Collection Only)
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Florida
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Miami, Florida, Forente stater, 33143
- Rekruttering
- BAPTIST ALLIANCE - MCI (Data Collection Only)
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Ta kontakt med:
- Ian Bostock, MD
- Telefonnummer: 786-596-2000
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Illinois
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Libertyville, Illinois, Forente stater, 60048
- Rekruttering
- Advocate Health Care Network
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Ta kontakt med:
- Michael Breen, MD
- Telefonnummer: 847-367-6781
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Kentucky
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Lexington, Kentucky, Forente stater, 40536-0093
- Fullført
- University of Kentucky (Data Collection Only)
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Michigan
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Traverse City, Michigan, Forente stater, 49684
- Fullført
- Munson Healthcare (Data Collection Only)
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Rekruttering
- Hackensack Meridian Health (Data collection only)
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Ta kontakt med:
- David Greenberg, MD
- Telefonnummer: 551-996-8704
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Rekruttering
- Roswell Park Cancer Institute (Data Collection Only)
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Ta kontakt med:
- Elisabeth Dexter, MD
- Telefonnummer: 716-845-2300
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Ta kontakt med:
- Smita Banerjee, PhD
- Telefonnummer: 646-888-0011
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Rekruttering
- Fox Chase Cancer Center (Data Collection Only)
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Ta kontakt med:
- Linda Fleisher, PhD, MPH
- Telefonnummer: 215-728-4066
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Philadelphia, Pennsylvania, Forente stater, 19104-4283
- Rekruttering
- University of Pennsylvania (Data Collection Only)
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Ta kontakt med:
- Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP
- Telefonnummer: (215) 615-5858
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Philadelphia, Pennsylvania, Forente stater, 08060
- Fullført
- Virtua Health (Data Collection Only)
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Virginia
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Chesapeake, Virginia, Forente stater, 23320
- Rekruttering
- Chesapeake Regional Healthcare (Data Collection Only)
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Ta kontakt med:
- Stephen Noble, MD
- Telefonnummer: 757-842-4499
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
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Patient under the care of a participating OCP as per self report;
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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
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Is at least 18 years of age as per self report;
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Has a history of suspicious lung mass or confirmed lung cancer diagnosis, as per clinician judgment or medical record note;
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Is a former or current smoking as per self report;
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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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 |
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Aktiv komparator: 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 |
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Eksperimentell: 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 |
|
Aktiv komparator: Participants with Lung Cancer-control group
Waitlist control group - WLC |
Standard of Care participant interaction |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Uptake of communication skills using standardized patient assessment/SPAs
Tidsramme: 3 months
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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
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Uptake of empathy skills using standardized patient assessment/SPAs
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Smita Banerjee, PhD, Memorial Sloan Kettering Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
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Studiet fullført (Antatt)
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Først innsendt som oppfylte QC-kriteriene
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Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 21-339
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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.
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