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临床试验/NCT01329068
NCT01329068Unknown不适用

Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
320
试验地点
2
主要终点
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)

时间窗: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.

次要结局

  • Questionnaires for patients and health care professionals, observations and user measurements of the iPads.(BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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