A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Nova Scotia
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Halifax、Nova Scotia、加拿大
- 招聘中
- Capital District
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接触:
- Deborah L McLeod
- 电话号码:902-473-2964
- 邮箱:DeborahL.McLeod@cdha.nshealth.ca
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首席研究员:
- Deborah L McLeod, R.N., Ph.D.
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Couples Prostate Cancer Support Group
The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). |
The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions. In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). |
无干预:Wait-List Control
Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change in Sexual Function from Baseline to 13 weeks
大体时间:Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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次要结果测量
结果测量 |
大体时间 |
---|---|
Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks
大体时间:Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Profile of Mood States Short Form from baseline to 13 weeks
大体时间:Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
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Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
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合作者和调查者
调查人员
- 首席研究员:Deborah L McLeod, R.N., Ph.D.、Capital District Health Authority & Dalhousie University
- 首席研究员:Richard J Wassersug, Ph.D.、University of British Columbia
- 首席研究员:Karen Fergus, Ph.D., C. Psych.、Sunnybrook Odette Cancer Centre & York University
- 首席研究员:John Robinson, Ph.D., C. Psych.、Tom Baker Cancer Centre & University of Calgary
- 首席研究员:John Oliffe, R.N, Ph.D.、University of British Columbia
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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