跳至主要内容
临床试验/NCT01108224
NCT01108224已完成不适用

Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study

Danish Cancer Society0 个研究点目标入组 210 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
主要终点
Quality of life

研究概览

简要总结

The purpose of this study is to determine whether an intervention to breast cancer patients including psycho-education and group psychotherapy can enhance quality of life and survival.

详细描述

PURPOSE: This randomized study included patients diagnosed with breast cancer who participated in an intervention including education and group psychotherapy lasting 10 weeks after surgery. The purpose of the study was to enhance Quality of Life, coping and social relations and to support the women when going through treatment. PATIENTS AND METHODS: We randomly assigned 210 patients with primary breast cancer to a control or an intervention group. Patients in the intervention group were offered 2 weekly 6-hour sessions of psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and nonparticipants were followed up for QoL, coping and social relations after one, six and twelve months post intervention and on vital status 5 years after surgical treatment.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Eligible patients were 18-70 years of age with stage I-IIIA primary breast cancer

排除标准

  • Distant metastasis
  • Not speaking or understanding Danish
  • Over 71 years
  • Other life-threatening diseases
  • Brain-damaged

结局指标

主要结局

Quality of life

时间窗: 12 months post intervention

Does Quality of Life enhance among a group of primary breast cancer patients who participate in a psychosocial group intervention compared to a control group of primary breast cancer patients who do not recieve any psychosocial intervention?

次要结局

  • Survival(5 years post surgery)

研究者

申办方类型
Other

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