がん治療提供者向けの共感的コミュニケーション スキル トレーニングにより、患者が経験する肺がんの偏見をなくすことができます
肺がんのスティグマを軽減するための共感的コミュニケーションスキルトレーニング
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jamie Ostroff, PhD
- 電話番号：646-888-0041
- メール：ostroffj@mskcc.org
研究連絡先のバックアップ
- 名前：Smita Banerjee, PhD
- 電話番号：646-888-0011
- メール：banerjes@mskcc.org
研究場所
-
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California
-
Irvine、California、アメリカ、92612
- 完了
- Providence St. Joseph Health (Data Collection Only)
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Florida
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Miami、Florida、アメリカ、33143
- 募集
- BAPTIST ALLIANCE - MCI (Data Collection Only)
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コンタクト：
- Ian Bostock, MD
- 電話番号：786-596-2000
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Illinois
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Libertyville、Illinois、アメリカ、60048
- 募集
- Advocate Health Care Network
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コンタクト：
- Michael Breen, MD
- 電話番号：847-367-6781
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Kentucky
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Lexington、Kentucky、アメリカ、40536-0093
- 完了
- University of Kentucky (Data Collection Only)
-
-
Michigan
-
Traverse City、Michigan、アメリカ、49684
- 完了
- Munson Healthcare (Data Collection Only)
-
-
New Jersey
-
Hackensack、New Jersey、アメリカ、07601
- 募集
- Hackensack Meridian Health (Data collection only)
-
コンタクト：
- David Greenberg, MD
- 電話番号：551-996-8704
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New York
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Buffalo、New York、アメリカ、14263-0001
- 募集
- Roswell Park Cancer Institute (Data Collection Only)
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コンタクト：
- Elisabeth Dexter, MD
- 電話番号：716-845-2300
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New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
コンタクト：
- Smita Banerjee, PhD
- 電話番号：646-888-0011
-
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- 募集
- Fox Chase Cancer Center (Data Collection Only)
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コンタクト：
- Linda Fleisher, PhD, MPH
- 電話番号：215-728-4066
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Philadelphia、Pennsylvania、アメリカ、19104-4283
- 募集
- University of Pennsylvania (Data Collection Only)
-
コンタクト：
- Victoria Sherry, DNP, CRNP, ANP-BC, AOCNP
- 電話番号：(215) 615-5858
-
Philadelphia、Pennsylvania、アメリカ、08060
- 完了
- Virtua Health (Data Collection Only)
-
-
Virginia
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Chesapeake、Virginia、アメリカ、23320
- 募集
- Chesapeake Regional Healthcare (Data Collection Only)
-
コンタクト：
- Stephen Noble, MD
- 電話番号：757-842-4499
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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;
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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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
アクティブコンパレータ：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 |
|
実験的：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 |
|
アクティブコンパレータ：Participants with Lung Cancer-control group
Waitlist control group - WLC |
Standard of Care participant interaction |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Uptake of communication skills using standardized patient assessment/SPAs
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Smita Banerjee, PhD、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 21-339
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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