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临床试验/NCT03026374
NCT03026374Unknown不适用

Effect of a Mentor-based, Supportive-expressive Program on Survival in Metastatic Breast Cancer

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
204
试验地点
1
主要终点
3- and 5-year survival

研究概览

简要总结

Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide. Additionally, 30% of early breast cancer turns metastatic, which is often incurable. Different from women with early breast cancer, women with metastatic breast cancer(MBC)must receive lifelong treatment, experience higher levels of emotional/physical distress, and feel frequent uncertainty about their health/possible death. They are also challenged to manage distressing adverse effects induced by different adjuvant treatments and experience heavy self-care demands during the transition period from being a patient to being a survivor. Thus, specific interventions to help women with metastatic breast cancer to recover from this traumatic event have been designed, and one of these is supportive-expressive group therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT on survival is inconsistent. Initial studies examining SEGT have reported a mean survival advantage of 18 months, however, these findings could not later be replicated.Yet, no study has reported a survival disadvantage for those given SEGT. In addition, we found no published articles on the application of SEGT among women with MBC in China. Owing to this dearth of previous research, it is unclear whether this therapy would exhibit positive effects within Chinese culture. Thus, we developed a "Be Resilient to Breast Cancer"(BRBC) program that is culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is designed to increase resilience(defined as the capacity to bounce back after encountering a traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and eventually prolong longevity. To better adapt to Chinese culture, we added education hosted by professional staff (e.g., clinical psychologists, dietician, Chinese medicine practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain, fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control, meditation, etc.),and to help patients gain a sense of control in their life. Second, trained mentors, who were breast cancer survivors themselves, were added to the group discussion to create non-hierarchical, reciprocal relationships through the sharing of experiences with those facing similar challenges. These mentors also provided women with first-hand information about treatment and offered suggestions to combat barriers to recovery.

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
Single (Outcomes Assessor)

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

  • (1) women with confirmed breast cancer, stratified by stage(II,III, and IV),(2) metastases outside of the breast and ipsilateral axilla, and (3) fluent in oral Mandarin or Cantonese.

排除标准

  • (1) central nervous system metastases, (2) a history of repeated suicidal behavior, (3) active psychosis or severe character disorder, (4) a life expectancy of less than 3 months(as assessed by primary oncologist), and/or (5)declined to participate in the program

结局指标

主要结局

3- and 5-year survival

时间窗: 3 and 5 years since intervention

次要结局

  • Anxiety(baseline, 2 months, 6 months, and 12 months since intervention)
  • Resilience(baseline, 2 months, 6 months, and 12 months since intervention)
  • Quality of Life(baseline, 2 months, 6 months, and 12 months since intervention)
  • Depression(baseline, 2 months, 6 months, and 12 months since intervention)
  • allostatic load index(ALI)(baseline, 2 months, 6 months, and 12 months since intervention)

研究者

发起方
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeng Jie Ye

Doctor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

研究点 (1)

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