通过患者和提供者的干预改善以患者为中心的乳腺癌沟通 (SHARES)
改善乳腺癌中以患者为中心的沟通：共享决策参与系统 (SHARES) 的随机对照试验
This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.
研究概览
地位
条件
- 解剖学 I 期乳腺癌 AJCC v8
- 解剖学 IA 期乳腺癌 AJCC v8
- 解剖学 IB 期乳腺癌 AJCC v8
- 解剖学 II 期乳腺癌 AJCC v8
- 解剖学 IIA 期乳腺癌 AJCC v8
- 解剖学 IIB 期乳腺癌 AJCC v8
- 解剖学 III 期乳腺癌 AJCC v8
- 解剖学 IIIA 期乳腺癌 AJCC v8
- 解剖学 IIIB 期乳腺癌 AJCC v8
- 解剖学 IIIC 期乳腺癌 AJCC v8
- 预后 I 期乳腺癌 AJCC v8
- 预后 IA 期乳腺癌 AJCC v8
- 预后 IB 期乳腺癌 AJCC v8
- 预后 II 期乳腺癌 AJCC v8
- 预后 IIA 期乳腺癌 AJCC v8
- 预后 IIB 期乳腺癌 AJCC v8
- 预后 III 期乳腺癌 AJCC v8
- 预后 IIIA 期乳腺癌 AJCC v8
- 预后 IIIB 期乳腺癌 AJCC v8
- 预后性 IIIC 期乳腺癌 AJCC v8
- 0 期乳腺癌解剖学 AJCC v8
- 预后 0 期乳腺癌 AJCC v8
详细说明
The primary and key secondary objectives of the study:
PRIMARY OBJECTIVES:
I. To demonstrate that the enhanced iCanDecide (iCanDecide-emotional support enhancement [ESE]) intervention is more effective than the standard version (iCanDecide-standard [S]) resulting in higher patient knowledge about locoregional treatment risks and benefits.
II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about locoregional treatment risks and benefits.
SECONDARY OBJECTIVES:
I. To demonstrate that the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.
II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.
OUTLINE: This study is a multi-level trial of SHaDES that has two interventions in a factorial or crossed design: 1) an individually randomized patient-level randomized controlled trial (RCT) to evaluate the standard version (iCanDecide-S) vs. a version with innovative emotional support enhancements (iCanDecide-ESE), and 2) a clinic-level stepped-wedge cluster randomized trial to test a Clinician Dashboard (CDB). Twenty-five surgical practices will be recruited for participation. Practices will be randomized to the timing of the CDB intervention, with some practices initiating the CDB intervention right away, while others may initiate the CDB later or perhaps be randomized to "no CDB" period. Clinicians will be asked to use the CDB beginning in the time period to which their practice was randomized and continuing to the end of the study. After registration, clinicians are followed up at 9 and 18 months. After a patient is registered, the patient will be randomized to one of two arms:
ARM I: Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
ARM II: Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.
After study registration, patients are followed up at 4-5 weeks and 9 months.
Patients will be enrolled at participating clinics during the full duration of the study and all enrolled patients will receive a version of the decision support tool (iCanDecide-S; iCanDecide-ESE). These patient-level activities are not influenced by the timing of the practice-level randomization to the CDB.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Vallejo、California、美国、94589
- Kaiser Permanente-Vallejo
-
-
Delaware
-
Newark、Delaware、美国、19713
- Helen F Graham Cancer Center
-
Rehoboth Beach、Delaware、美国、19971
- Beebe Health Campus
-
-
Georgia
-
Savannah、Georgia、美国、31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
Hawaii
-
Honolulu、Hawaii、美国、96819
- Kaiser Permanente Moanalua Medical Center
-
-
Illinois
-
Mount Vernon、Illinois、美国、62864
- SSM Health Good Samaritan
-
-
Maine
-
Scarborough、Maine、美国、04074
- Maine Medical Center- Scarborough Campus
-
-
Michigan
-
Grand Rapids、Michigan、美国、49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo、Michigan、美国、49007
- West Michigan Cancer Center
-
Kalamazoo、Michigan、美国、49048
- Ascension Borgess Hospital
-
-
New York
-
Mount Kisco、New York、美国、10549
- Northern Westchester Hospital
-
New York、New York、美国、10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
The Bronx、New York、美国、10461
- Montefiore Medical Center-Einstein Campus
-
-
North Carolina
-
Greensboro、North Carolina、美国、27403
- Novant Health Breast Surgery - Greensboro
-
-
North Dakota
-
Bismarck、North Dakota、美国、58501
- Sanford Bismarck Medical Center
-
Fargo、North Dakota、美国、58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Chillicothe、Ohio、美国、45601
- Adena Regional Medical Center
-
Westerville、Ohio、美国、43081
- Saint Ann's Hospital
-
Zanesville、Ohio、美国、43701
- Genesis Healthcare System Cancer Care Center
-
-
Tennessee
-
Memphis、Tennessee、美国、38120
- Baptist Memorial Hospital for Women
-
-
Wisconsin
-
Appleton、Wisconsin、美国、54911
- ThedaCare Regional Cancer Center
-
Eau Claire、Wisconsin、美国、54701
- Marshfield Medical Center-EC Cancer Center
-
Grafton、Wisconsin、美国、53024
- Aurora Cancer Care-Grafton
-
La Crosse、Wisconsin、美国、54601
- Gundersen Lutheran Medical Center
-
Wausau、Wisconsin、美国、54401
- Aspirus Regional Cancer Center
-
Wauwatosa、Wisconsin、美国、53226
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
-
West Allis、Wisconsin、美国、53227
- Aurora West Allis Medical Center
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- PATIENT ELIGIBILITY
- Women newly diagnosed with stage 0-III breast cancer. Although men are recommended to undergo surgery to treat breast cancer, male breast cancer is relatively rare and decision making for breast cancer surgery is quite different between men and women
- Planning breast surgery as a component of their definitive treatment within 5 weeks of registration
- Receives care from a clinician and at a practice that has consented to participate in the clinician dashboard practice-level intervention. Practices/clinicians will consent initially at the initiation of the study. Patients will then be identified and recruited in those practices. If a practice has more than one clinician doing breast surgery, patients will be recruited from those clinicians who consent (one or more). Patients of clinicians who have not consented will not be eligible
- Patients must be able to speak English or Spanish with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
- Age 21-84 years
- CLINICIAN STAKEHOLDER (SURGEONS AND CLINIC STAFF) ELIGIBILITY CRITERIA
- Clinicians eligible for this study include: breast surgeons and their designee(s) (e.g., physician assistants, nurse practitioners, clinical nurse specialists, or nurses) that participate in the treatment decision-making process. At least one surgical oncologist at a practice must agree to participate and sign consent. S/he may then also identify a nurse, physician assistant (PA) or advanced practice provider (APP) with whom s/he works that is involved in the delivery of the care of the same patients to participate. Henceforth, in this protocol they will be referred to as "clinicians"
- Clinicians must agree to have their patients recruited for the entire time the study is open at their practice, which will include time periods in which the clinicians will and time periods in which they will not have access to the CDB
- INSTITUTION ELIGIBILITY:
- Practices that annually provide surgical care for over 100 patients newly diagnosed with breast cancer are eligible to participate in this study
- Eligible practices must have at least one surgical oncologist who agrees to participate in the study
Exclusion Criteria:
- Patients who are visually impaired are not eligible, as they must be able to access the study intervention on a website at home or in clinic and view the decision aid
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study
学习计划
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：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm I: (iCanDecide - ESE)
Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration. |
Ancillary studies Participate in interview Undergo surgery Ancillary studies Utilize the iCanDecide - ESE website |
|
有源比较器：Arm II: (iCanDecide - S)
Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration. |
Ancillary studies Participate in interview Undergo surgery Ancillary studies Utilize the iCanDecide - S website |
|
实验性的：Clinics 1-5: (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 1-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
实验性的：Clinics 6-8 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 10-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
实验性的：Clinics 9-11 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 20-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
实验性的：Clinics 12-14 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 30-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
实验性的：Clinics 15-17 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 40-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
实验性的：Clinics 18-20 (CDB)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 50-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
有源比较器：Clinics 21-25 (usual care)
Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and continue to provide breast cancer surgical care per their usual care. Clinicians may also participate in an audio-recorded phone interview over 20 minutes. |
Participate in interview Ancillary studies Receive training Utilize usual care |
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 Knowledge About Risks and Benefits of Local Regional Treatment
大体时间：5 weeks
|
Will be defined as the mean percentage of correct answers (range: 0-100%) from a 5-item scale previously developed and pilot tested where higher percentages indicate increased knowledge of treatment risks and benefits of local regional treatment. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous primary outcome measure patient knowledge. |
5 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Self-efficacy in Dealing With Breast Cancer
大体时间：5 weeks
|
Will be defined as the composite score obtained from the 11-item (each rated on a 5-point Likert scale: "strongly disagree" to "strongly agree") validated scale designed to assess breast cancer patients' overall feelings of control of their cancer and worry about their cancer (range: 11 to 55); higher scores indicate increased self-efficacy. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient self-efficacy. |
5 weeks
|
|
Patient Cancer Worry
大体时间：5 weeks
|
Will be defined as the total score obtained from the 8-item (each rated on a 4-point Likert scale: "never" to "almost always") validated Cancer Worry Scale assessing the degree of cancer-related worry (range: 8 to 40); higher scores indicate more frequent worries about cancer. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient cancer worry. |
5 weeks
|
合作者和调查者
调查人员
- 学习椅：Sarah T. Hawley, PhD, MPH、University of Michigan School of Medicine and Public Health
出版物和有用的链接
一般刊物
- Hawley ST, Kidwell KM, Jagsi R, Barber AK, Wills R, Chow SL, Kour O, Segovia D, Abrahamse P, Resnicow K, Zikmund-Fisher BJ, Hofer TP, Neuman HB. Evaluating a shared decision engagement system in the NCI community oncology research program: a multi-level RCT. JNCI Cancer Spectr. 2026 Sep 28:pkag100. doi: 10.1093/jncics/pkag100. Online ahead of print.
- Hawley ST, Kidwell K, Zahrieh D, McCarthy A, Wills R, Rankin A, Hofer T, Chow S, Jagsi R, Neuman H. Improving patient-centered communication in breast cancer: a study protocol for a multilevel intervention of a shared treatment deliberation system (SharES) within the NCI community oncology research program (NCORP) (Alliance A231901CD). Trials. 2023 Jan 6;24(1):16. doi: 10.1186/s13063-022-07048-4.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- A231901CD
- NCI-2020-06176 (注册表标识符：NCI Clinical Trial Reporting Program)
- UG1CA189823 (美国 NIH 拨款/合同)
- R01CA237046 (美国 NIH 拨款/合同)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.