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临床试验/NCT01716702
NCT01716702已完成不适用

A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

Nova Scotia Health Authority1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年7月9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
18
试验地点
1
主要终点
Change in Sexual Function from Baseline to 13 weeks

研究概览

简要总结

Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.

Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.

What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.

Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Men who have been treated for localized prostate cancer
  • AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer
  • Must have a heterosexual, co-cohabiting partner who is willing to participate
  • Must speak and read English
  • Must be able to use a computer and have internet access

排除标准

  • Homosexual couples will not be included in this study
  • Major self-reported psychiatric illness
  • Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)

结局指标

主要结局

Change in Sexual Function from Baseline to 13 weeks

时间窗: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

次要结局

  • Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks(Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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