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临床试验/NCT00418444
NCT00418444已完成不适用

Randomized Control Trial of a Group Therapy Intervention Addressing Body Image and Psychosocial Functioning for Women With Breast Cancer

University Health Network, Toronto4 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2007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
180
试验地点
4
主要终点
Self image and communication(using standardized instruments)

研究概览

简要总结

The purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, quality of life, psychosocial/sexuality/relational functioning.

详细描述

Breast cancer is the most frequently diagnosed cancer in women with 1 in 10 Canadian women being diagnosed in their lifetime. There has been an increase in the number of survivors due to advances in treatment and early detection, and increased scientific attention has been focused on patients' quality of life during and after treatment. The majority of survivors do well after the initial adjustment within the first 2 years post-treatment. However, depending on when assessed after treatment completion, a wide range of cancer survivors either score at levels suggestive of a psychiatric diagnosis or are diagnosed with a psychological problem. Furthermore, a subset of survivors experience adjustment problems long after treatment completion. Approximately 20% to 40% of survivors develop sexual and body image problems following breast cancer and treatment and these difficulties tend to persist several years after treatment completion.

This study aims to test an innovative intervention geared towards issues of identity, body image and sexuality and to examine the intervention for its impact on body image and quality of life, psychosocial and sexual functioning and relational functioning.

One hundred and eighty women who have completed treatment for breast cancer will be randomized into either intervention: an 8 weekly psychosocial group support or control condition (standard care + written educational material). All subjects will be followed for 1 year post-intervention. It is hypothesized that, compared to control subjects who receive standard care and educational materials, subjects participating in an 8 weekly psychosocial group support will have higher levels of relationship support/functioning, and that the group differences will be maintained over the 1-year follow up period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women with primary breast cancer
  • age between 18 and 65 years
  • completed adjuvant treatments
  • Stage I,II,III cancer of the breast with no metastatic disease

排除标准

  • presence of any metastases
  • history of major psychiatric disorder as defined by the DSM-IV
  • inability to speak or read English for questionnaire completion
  • failure to provide informed consent
  • currently participating in a therapist-led psychosocial support group

结局指标

主要结局

Self image and communication(using standardized instruments)

次要结局

  • Psychosocial and psychosexual functioning (using standardized instruments)
  • Relational functioning, quality of life and health care utilization (using standardized instruments)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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