- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05456841
Empaattisten kommunikaatiotaitojen koulutus syöpähoidon tarjoajille, jotka auttavat lopettamaan potilaiden kokeman keuhkosyövän leimautumisen
Empaattisten kommunikaatiotaitojen koulutus keuhkosyövän leimautumisen vähentämiseksi
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Jamie Ostroff, PhD
- Puhelinnumero: 646-888-0041
- Sähköposti: ostroffj@mskcc.org
Tutki yhteystietojen varmuuskopiointi
- Nimi: Smita Banerjee, PhD
- Puhelinnumero: 646-888-0011
- Sähköposti: banerjes@mskcc.org
Opiskelupaikat
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California
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Irvine, California, Yhdysvallat, 92612
- Valmis
- Providence St. Joseph Health (Data Collection Only)
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Florida
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Miami, Florida, Yhdysvallat, 33143
- Rekrytointi
- BAPTIST ALLIANCE - MCI (Data Collection Only)
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Ottaa yhteyttä:
- Ian Bostock, MD
- Puhelinnumero: 786-596-2000
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Illinois
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Libertyville, Illinois, Yhdysvallat, 60048
- Rekrytointi
- Advocate Health Care Network
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Ottaa yhteyttä:
- Michael Breen, MD
- Puhelinnumero: 847-367-6781
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Kentucky
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Lexington, Kentucky, Yhdysvallat, 40536-0093
- Valmis
- University of Kentucky (Data Collection Only)
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Michigan
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Traverse City, Michigan, Yhdysvallat, 49684
- Valmis
- Munson Healthcare (Data Collection Only)
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New Jersey
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Hackensack, New Jersey, Yhdysvallat, 07601
- Rekrytointi
- Hackensack Meridian Health (Data collection only)
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Ottaa yhteyttä:
- David Greenberg, MD
- Puhelinnumero: 551-996-8704
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New York
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Buffalo, New York, Yhdysvallat, 14263-0001
- Rekrytointi
- Roswell Park Cancer Institute (Data Collection Only)
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Ottaa yhteyttä:
- Elisabeth Dexter, MD
- Puhelinnumero: 716-845-2300
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New York, New York, Yhdysvallat, 10065
- Rekrytointi
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Ottaa yhteyttä:
- Smita Banerjee, PhD
- Puhelinnumero: 646-888-0011
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19111
- Rekrytointi
- Fox Chase Cancer Center (Data Collection Only)
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Ottaa yhteyttä:
- Linda Fleisher, PhD, MPH
- Puhelinnumero: 215-728-4066
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Philadelphia, Pennsylvania, Yhdysvallat, 19104-4283
- Rekrytointi
- University of Pennsylvania (Data Collection Only)
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Ottaa yhteyttä:
- Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP
- Puhelinnumero: (215) 615-5858
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Philadelphia, Pennsylvania, Yhdysvallat, 08060
- Valmis
- Virtua Health (Data Collection Only)
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Virginia
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Chesapeake, Virginia, Yhdysvallat, 23320
- Rekrytointi
- Chesapeake Regional Healthcare (Data Collection Only)
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Ottaa yhteyttä:
- Stephen Noble, MD
- Puhelinnumero: 757-842-4499
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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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Active Comparator: 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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Kokeellinen: 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 |
|
Active Comparator: Participants with Lung Cancer-control group
Waitlist control group - WLC |
Standard of Care participant interaction |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Uptake of communication skills using standardized patient assessment/SPAs
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Smita Banerjee, PhD, Memorial Sloan Kettering Cancer Center
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 21-339
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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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