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Patient Empowerment by Group Medical Consultations (GMC)

2012年1月19日 更新者:Radboud University Medical Center

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

介入性

注册 (预期的)

320

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

    • Gelderland
      • Nijmegen、Gelderland、荷兰、6500 HB
        • 招聘中
        • Radboud University Nijmegen Medical Centre
        • 首席研究员:
          • H.W.M. van Laarhoven, Md

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

有资格学习的性别

女性

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

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: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
有源比较器:Individual consult
regular individual consult
regular individual consultations
有源比较器:group medical consult
regular group medical consult
group medical consult

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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.
BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.

次要结果测量

结果测量
措施说明
大体时间
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.
  • Cancer worry (CWS)
  • Quality of life (EORTC QLQ C30 and BR23)
  • Compliance to hormonal treatment (MARS) (for breast cancer only)
  • Cost-effectiveness (TIC-P- part 1 and EuroQol-5D)
  • Information needs and giving
  • Self-breast examination (for BRCA only)
  • Decisions for prophylactic mastectomy or surveillance (for BRCA only)
  • Patient satisfaction

IPads:

  • Frequency of using the iPad
  • Content of use
  • Frequency and ways of contacting other patients
  • Content of the online meetings
BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.

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。

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

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。

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

2011年4月1日

初级完成 (预期的)

2014年2月1日

研究完成 (预期的)

2014年2月1日

研究注册日期

首次提交

2011年3月31日

首先提交符合 QC 标准的

2011年4月4日

首次发布 (估计)

2011年4月5日

研究记录更新

最后更新发布 (估计)

2012年1月20日

上次提交的符合 QC 标准的更新

2012年1月19日

最后验证

2011年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • UMCNONCO201006

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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