Involving Family to Improve Communication in Breast Cancer Care
研究概览
详细说明
Breast cancer is the most common cancer among survivors in the US. Most patients with breast cancer receive help from family in making complex decisions about treatment, handling logistically demanding care coordination, and managing symptoms and side effects. Although family members (as defined by each patient) play a vital role in cancer care, they are not formally recognized or assessed in care delivery, and their need for information and support is typically unmet. Lack of attention to family in care delivery is an important gap that too often leaves families without adequate information about patient health and treatments. This may prevent families and patients from engaging in open conversations, cause them unnecessary anxiety, and negatively affect the quality of cancer care and delivery.
Communication is particularly important in cancer care, as the optimal course of action is determined through longitudinal discussion of prognosis, treatments, and patient goals, preferences, and concerns. Strategies to improve communication for serious illnesses such as cancer have been developed, but typically target a specific decision, conversation, or setting, most often the inpatient hospital. There is growing agreement that communication among patients, families, and providers should be initiated early and continue throughout the disease trajectory. However, little is known about how to provide both patients and families with access to timely information about patient health and mechanisms to communicate directly with health care providers, as proposed in this study.
The goal of this study is to test a multicomponent intervention to strengthen communication and longitudinal partnerships among women with breast cancer and their family members. Recent work by the study team has demonstrated the feasibility, acceptability, and benefit of intervention components which will be combined into a single model of care. The study team's preliminary studies indicate that clarifying patient and family expectations regarding the role of family and providing family with timely and comprehensive information about patient health (as desired by the patient) leads to more effective family involvement, more frequent patient-family-provider interactions, more patient-centered communication, and greater preparedness to manage care.
This study will evaluate the feasibility of delivering a multicomponent communication intervention in the outpatient setting comprising: 1.) a patient-family agenda-setting checklist completed immediately before a regularly scheduled medical oncology visit with a participating medical oncologist, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes. The study will focus on patients who typically attend medical oncology visits with a family member or trusted friend who are already present and involved in communication. This study will enroll up to 132 patients who are on active treatment for breast cancer, up to 132 family member/friend "companions" and up to 14 medical oncology providers. The study team will compare patients and companions who are in the intervention group (n=60 dyads) with patients and companions who are in the control group and receive usual medical oncology care (n=60 dyads). This study will compare quality of communication with medical oncology providers, understanding of patient's cancer, confidence in managing patient's care, satisfaction with cancer care, and symptoms of anxiety after 3 months, 9 months, and 12 months of follow-up.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21231
- Johns Hopkins Kimmel Cancer Center - Medical Oncology
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Lutherville、Maryland、美国、21093
- Johns Hopkins Kimmel Cancer Center at Green Spring Station - Medical Oncology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Medical oncology patient: Established patient of participating medical oncologist greater than 18 years of age, have a diagnosis of early stage or advanced breast cancer, are receiving active systemic therapy (in the form of IV adjuvant systemic therapy if early stage), are English speaking, able to provide informed consent themselves, and identify a family member who they would like to include in their care.
- Care partner: Family member (e.g. spouse, adult child, parent, adult sibling or other relative) or unpaid friend who regularly accompanies patient to medical oncology visits.
- Medical oncology provider: Practicing medical oncology provider at a participating clinic who provides care to patients with breast cancer.
Exclusion Criteria:
- Medical oncology patients: Younger than 18 years, pregnant, not being treated for breast cancer, do not attend medical oncology visits with family member or unpaid friend or unwilling for their family member or unpaid friend to be contacted.
- Care partner: Paid non-family member who accompanies patient to visits.
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:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Multicomponent Intervention
1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.
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1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes.
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安慰剂比较:Usual Care
Care as usual with the medical oncologist.
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Routine medical oncology care
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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 |
---|---|---|
Between-group Differences in Patient Complete Illness Understanding at 9-months
大体时间:9 months
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Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life.
We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
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9 months
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Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months
大体时间:9 months
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Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care.
Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination.
Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
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9 months
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Between-group Differences in Patient Anxiety at 9-months
大体时间:9 months
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Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day").
Full range is 0-6 with higher scores indicating more anxiety.
Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
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9 months
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Between-group Differences in Care Partner Complete Illness Understanding at 9-months
大体时间:9 months
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Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life.
We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
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9 months
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Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months
大体时间:9 months
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Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care.
Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination.
Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
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9 months
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Between-group Differences in Care Partner Anxiety at 9-months
大体时间:9 months
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Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day").
Full range is 0-6 with higher scores indicating more anxiety.
Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
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9 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Between-group Differences in Patient Quality of Communication at 9-months
大体时间:9 months
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Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team.
The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine').
Full range is 0-100 with higher scores indicating higher perceived quality of communication.
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9 months
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Between-group Differences in Care Partner Quality of Communication at 9-months
大体时间:9 months
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Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team.
The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine').
Full range is 0-100 with higher scores indicating higher perceived quality of communication.
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9 months
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合作者和调查者
调查人员
- 首席研究员:Antonio Wolff, MD、Johns Hopkins University
出版物和有用的链接
一般刊物
- Wolff JL, Berger A, Clarke D, Green JA, Stametz R, Yule C, Darer JD. Patients, care partners, and shared access to the patient portal: online practices at an integrated health system. J Am Med Inform Assoc. 2016 Nov;23(6):1150-1158. doi: 10.1093/jamia/ocw025. Epub 2016 Mar 28.
- Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.
- Delbanco T, Walker J, Bell SK, Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012 Oct 2;157(7):461-70. doi: 10.7326/0003-4819-157-7-201210020-00002. Erratum In: Ann Intern Med. 2015 Apr 7;162(7):532.
- Wolff JL, Aufill J, Echavarria D, Heughan JA, Lee KT, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Thorner E, Zafman N, Levy HP, Dy SM, Wolff AC. Sharing in care: engaging care partners in the care and communication of breast cancer patients. Breast Cancer Res Treat. 2019 Aug;177(1):127-136. doi: 10.1007/s10549-019-05306-9. Epub 2019 Jun 4.
- Wolff JL, Aufill J, Echavarria D, Blackford AL, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Zafman N, Thorner E, Levy HP, Guo A, Dy SM, Wolff AC. A randomized intervention involving family to improve communication in breast cancer care. NPJ Breast Cancer. 2021 Feb 12;7(1):14. doi: 10.1038/s41523-021-00217-9.
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
关键字
其他研究编号
- J1735
- IRB00129995 (其他标识符:JHMIRB)
- SAC170001 (其他赠款/资助编号:Susan G. Komen Breast Cancer Foundation)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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
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Checklist, MyChart, OpenNotes的临床试验
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University of California, Los AngelesCarnegie Mellon University完全的
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University of FloridaNational Center for Advancing Translational Sciences (NCATS)尚未招聘肥胖 | 腹疝