此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

增加患者对乳腺癌手术决策的参与度

2026年9月23日 更新者：Alliance for Clinical Trials in Oncology

通过共同决策干预增加社会经济弱势患者参与乳腺癌手术决策

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.

II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.

SECONDARY OBJECTIVES:

I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.

Trial Design:

OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.

ARM I: usual care

ARM II: decision aid intervention

The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.

研究类型

介入性

注册 (实际的)

627

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 关岛
      • Tamuning、关岛、96913
        • FHP Health Center-Guam
  • 波多黎各
      • San Juan、波多黎各、00902
        • Pan American Center for Oncology Trials LLC
  • 美国
    • California
      • Dublin、California、美国、94568
        • Epic Care-Dublin
      • Emeryville、California、美国、94608
        • Bay Area Breast Surgeons Inc
      • Emeryville、California、美国、94608
        • Epic Care Partners in Cancer Care
      • Martinez、California、美国、94553-3156
        • Contra Costa Regional Medical Center
      • Oakland、California、美国、94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland、California、美国、94609
        • Bay Area Tumor Institute
      • Walnut Creek、California、美国、94597
        • Epic Care Cyberknife Center
    • Georgia
      • Augusta、Georgia、美国、30912
        • Augusta University Medical Center
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • Queen's Medical Center
      • Honolulu、Hawaii、美国、96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu、Hawaii、美国、96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu、Hawaii、美国、96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu、Hawaii、美国、96813
        • Straub Clinic and Hospital
      • Honolulu、Hawaii、美国、96813
        • University of Hawaii Cancer Center
      • Honolulu、Hawaii、美国、96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu、Hawaii、美国、96817
        • Kuakini Medical Center
      • Honolulu、Hawaii、美国、96817
        • Queen's Cancer Center - Kuakini
      • Honolulu、Hawaii、美国、96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu、Hawaii、美国、96813
        • Island Urology
      • Lihue、Hawaii、美国、96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea、Hawaii、美国、96701
        • Pali Momi Medical Center
      • ‘Aiea、Hawaii、美国、96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea、Hawaii、美国、96701
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Aiea、Hawaii、美国、96701
        • Hawaii Cancer Care - Savio
    • Idaho
      • Boise、Idaho、美国、83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell、Idaho、美国、83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene、Idaho、美国、83814
        • Kootenai Health - Coeur d'Alene
      • Emmett、Idaho、美国、83617
        • Walter Knox Memorial Hospital
      • Meridian、Idaho、美国、83642
        • Idaho Urologic Institute-Meridian
      • Nampa、Idaho、美国、83686
        • Saint Alphonsus Medical Center-Nampa
      • Post Falls、Idaho、美国、83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint、Idaho、美国、83864
        • Kootenai Cancer Clinic
    • Illinois
      • Chicago、Illinois、美国、60612
        • John H Stroger Jr Hospital of Cook County
      • Danville、Illinois、美国、61832
        • Carle on Vermilion
      • Effingham、Illinois、美国、62401
        • Carle Physician Group-Effingham
      • Mattoon、Illinois、美国、61938
        • Carle Physician Group-Mattoon/Charleston
      • Urbana、Illinois、美国、61801
        • Carle Cancer Center
      • Urbana、Illinois、美国、61801
        • The Carle Foundation Hospital
    • Louisiana
      • New Orleans、Louisiana、美国、70121
        • Ochsner Medical Center Jefferson
    • Montana
      • Anaconda、Montana、美国、59711
        • Community Hospital of Anaconda
      • Billings、Montana、美国、59101
        • Billings Clinic Cancer Center
      • Bozeman、Montana、美国、59715
        • Bozeman Deaconess Hospital
      • Great Falls、Montana、美国、59405
        • Great Falls Clinic
      • Great Falls、Montana、美国、59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Helena、Montana、美国、59601
        • Saint Peter's Community Hospital
      • Kalispell、Montana、美国、59901
        • Kalispell Regional Medical Center
      • Missoula、Montana、美国、59804
        • Community Medical Hospital
    • New Mexico
      • Albuquerque、New Mexico、美国、87102
        • University of New Mexico Cancer Center
    • Oregon
      • Baker City、Oregon、美国、97814
        • Saint Alphonsus Medical Center-Baker City
      • Ontario、Oregon、美国、97914
        • Saint Alphonsus Medical Center-Ontario
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina
    • Virginia
      • Richmond、Virginia、美国、23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Wisconsin
      • Marshfield、Wisconsin、美国、54449
        • Marshfield Medical Center-Marshfield
    • Wyoming
      • Cody、Wyoming、美国、82414
        • Billings Clinic-Cody
      • Sheridan、Wyoming、美国、82801
        • Welch Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Newly diagnosed with stage 0-III breast cancer
  • Eligible patients must be planning breast surgery as a component of their definitive treatment
  • Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
  • Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
  • Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
  • CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
  • INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
  • INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Arm I (surgical consultation)

Prior to institutional crossover, participants receive care as per usual care.
其他：Usual Care

Usual Care
实验性的：Arm II (web-based breast cancer surgery decision aid)

Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
其他：Usual Care

Usual Care

其他：Web-based decision aid

Web-based decision aid received prior to the surgical consultation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Patient Power: Self-efficacy in Patient Physician Interactions
大体时间：3 weeks

Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
3 weeks
Patient Power: Active Patient Participation
大体时间：1 day

Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
1 day

次要结果测量

结果测量
措施说明
大体时间
Patient Knowledge
大体时间：Up to 3 weeks

Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
Up to 3 weeks
Percentage of Concordant Between Surgery Received and Patient Treatment Preference
大体时间：Up to 3 weeks

This binary outcome indicates whether the surgery received (mastectomy or lumpectomy) was concordant with the patient's treatment preference. Patient's goals/concerns (keep the breast, remove the breast for peace of mind, avoid radiation), rated from 0 (not at all important) to 10 (extremely important), and treatment preference (lumpectomy only, lumpectomy and radiation, mastectomy, other surgery, or not sure) are measured with the Decision Quality Instrument (DQI)-Breast Surgery survey, completed within 3 weeks post-consultation. Concordance is derived using the method of Sepucha et al. (2012): (1) estimate a predicted probability (pp) of surgery preference from a multivariable logistic regression model with patient's goals/concerns and stage as independent variables; (2) classify patients as concordant if pp >= 0.5 and mastectomy was received, or pp < 0.5 and lumpectomy was received; and (3) calculate the percentage of concordant.
Up to 3 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)

调查人员

  • 学习椅：Heather B. Neuman,, MD, MS、University of Wisconsin, Madison

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年6月5日

初级完成 (实际的)

2023年1月26日

研究完成 (实际的)

2023年5月30日

研究注册日期

首次提交

2018年11月30日

首先提交符合 QC 标准的

2018年12月4日

首次发布 (实际的)

2018年12月5日

研究记录更新

最后更新发布 (实际的)

2026年10月15日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • A231701CD
  • NCI-2018-00643 (注册表标识符：NCI Clinical Trial Reporting Program)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD 共享时间框架

Beginning 6 to 12 months following article publication.

IPD 共享访问标准

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅