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临床试验/NCT00335634
NCT00335634已完成不适用

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年6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
50
试验地点
2
主要终点
Semi-Structured Interview - Patient

研究概览

简要总结

The purpose of this study is to explore patient and partner experiences with sexual dysfunction following radical prostatectomy, in order to understand its effects on sexual and non-sexual intimacy. This will enable us to provide assistance in the future to individuals experiencing similar circumstances.

详细描述

We are studying the impact of sexual dysfunction following radical prostatectomy on patient and partners' experiences of intimacy. Research with men in post-radical prostatectomy recovery indicates 25%-75% experience sexual dysfunction. Many patients experience anxiety and distress related to sexual difficulties. These experiences may progress and result in long-term problems in the relationship between patients and their partners. Despite apparent levels of effectiveness, up to half of the patients who turn to sexually assistive aids after surgical removal of the prostate discontinue use of the aids within one year. Additionally, difficulties in communicating about sexual impairments can significantly interfere with the couples' ability to achieve successful adaptation. We are interested in studying patient and partner experiences with sexual dysfunction in order to understand its effects on sexual and non-sexual intimacy.

Participation in this study will involve completing 6 confidential face-to-face interviews on three separate occasions (3-6 months, 12-15 months, and 21-24 months post-surgery). On each occasion, participants will be required to take part in a "couple's" interview with his/her partner, as well as an individual interview. The interviews will provide participants with the opportunity to discuss the impact of sexual dysfunction on mood, thoughts, and communication with their partners. Demographic information will be collected at the initial interview. As well, at each of the 3 time points, participants will also be asked to complete a questionnaire package containing 6 psychological questionnaires. All questionnaires and interview material will be kept strictly confidential.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Radical prostatectomy treatment for prostate cancer at Princess Margaret Hospital or Etobicoke General Hospital
  • At least 3 months, but less than 6 months post-radical prostatectomy
  • Experience sexual dysfunction as a result of radical prostatectomy
  • Must have an intimate partner and be able to participate as a couple

排除标准

  • Detectable prostate specific antigen (PSA) post-radical prostatectomy
  • Patient or partner unable to speak English
  • Patient or partner unwilling to allow interviews to be recorded
  • Patient or partner unwilling to participate

结局指标

主要结局

Semi-Structured Interview - Patient

时间窗: 21-24 months post-radical prostatectomy

Semi-Structured Interview - Couple

时间窗: 21-24 months post-radical prostatectomy

Semi-Structured Interview - Partner

时间窗: 21-24 months post-radical prostatectomy

次要结局

  • The International Index of Erectile Function(21-24 months post-radical prostatectomy)
  • Dyadic Adjustment Scale(21-24 months post-radical prostatectomy)
  • Miller Social Intimacy Scale(21-24 months post-radical prostatectomy)
  • Brief Profile of Mood States(21-24 months post-radical prostatectomy)
  • Index of Sexual Life(21-24 months post-radical prostatectomy)
  • Hospital Anxiety and Depression Scale(21-24 months post-radical prostatectomy)
  • Sternberg Triangular Love Scale(21-24 months post-radical prostatectomy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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