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临床试验/NCT03571841
NCT03571841已完成不适用

Sexual Health and Rehabilitation After Ovarian Suppression Treatment (SHARE-OS): An Educational Intervention for Young Breast Cancer Survivors

Dana-Farber Cancer Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Sexual Function (FSFI)

研究概览

简要总结

This research study is evaluating an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence.

详细描述

The purpose of this research is to study the effectiveness of an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of cancer recurrence. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning.

  • This study consists of attending a group educational session followed by a one-on-one telephone coaching session.
  • The group educational session will last about 4 hours, and will include information on resources, self-help strategies, and relaxation techniques.
  • The telephone coaching session will take place four weeks after the group session, and will last about 15 minutes

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a history of breast cancer who are currently on chemical ovarian suppression
  • Current age ≤ 50
  • No active cancer therapy in the past 6 months and no future therapy planned
  • Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
  • English-speaking

排除标准

  • History of pelvic radiation
  • Prior participation in one of Dr. Bober's sexual health workshops

结局指标

主要结局

Change in Sexual Function (FSFI)

时间窗: Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up

Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)

次要结局

  • Change in participants psychological distress on Brief Symptom Inventory(Baseline to 2 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Bober, Ph.D

Prinicipal Investigator

Dana-Farber Cancer Institute

研究点 (2)

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