Patient Empowerment by Group Medical Consultations (GMC)
Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in the course of their lives . They face a difficult choice: either a preventive removal of the breast(s) or an intensive inspection process.
After primary treatment of breast cancer, patients will be followed for 5-10 years to diagnose recurrence or a new primary tumor in an early stage; to support the patient during hormonal treatment; to educate the patient about risk factors and healthy life style; and to provide psychosocial support.
Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is offered in regular, one-to-one medical visits. Experience shows that in an individual visit it is often not possible to give all aspects that are important, enough attention. The group medical consultation (GMC) is a new form of medical visits where the physician or nurse practitioner performs a series of one-to-one consultations in the presence of 8 to10 other patients. A social worker accompanies this process. Patients in group consultations may gather more information because they learn from each other and there is relatively more time compared to a regular consultation. Research shows that both patients and caregivers are more satisfied with care after a group consultation compared to individual visits. After a GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months. Using this iPad, patients can contact the women they have met during the GMC as well as health care professionals by several communication channels, including virtual group meetings. This approach provides a unique combination of both social support and professional education concerning survivorship in an e-health environment.However, it is also known that group sessions may be counterproductive for some patients, for example because they are frightened by the stories of others. The goal of this study is to examine whether group visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and for patients in follow-up after breast cancer.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Gelderland
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Nijmegen、Gelderland、荷兰、6500 HB
- 招聘中
- Radboud University Nijmegen Medical Centre
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首席研究员:
- H.W.M. van Laarhoven, Md
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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:
Participants: patients in follow-up after breast cancer
- Women ≥ 18 years of age with histologically proven breast cancer.
- Primary treatment (surgery, radiotherapy, chemotherapy) completed maximally 5 years ago.
Participants: women with a BRCA mutation
- Women ≥ 25 years of age with a proven BRCA1 or BRCA2 mutation.
- Carrier of a BRCA1 or BRCA2 mutation, diagnosed maximally two years before inclusion.
Exclusion Criteria:
Participants: patients in follow-up after breast cancer
- Metastatic breast cancer
- Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
- A history of prophylactic mastectomy.
- Current psychiatric disease precluding consultations in a group.
- Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire
Participants: women with a BRCA mutation
- Metastatic breast cancer
- Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
- A history of prophylactic mastectomy.
- Current psychiatric disease precluding consultations in a group.
- Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Individual consult
regular individual consult
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regular individual consultations
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有源比较器:group medical consult
regular group medical consult
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group medical consult
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
大体时间:BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
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BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Questionnaires for patients and health care professionals, observations and user measurements of the iPads.
大体时间:BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
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IPads:
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BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
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合作者和调查者
调查人员
- 首席研究员:H.W.M. van Laarhoven, Md PhD、Radboud University Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
individual consult的临床试验
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University of MinnesotaNational Institute of Mental Health (NIMH); Michigan Department of Community Health完全的