Mindfulness-based Therapy Group Intervention for Couple's Dealing With Sexual Dysfunction After Prostate-cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Sexual correlates: GMSEX
研究概览
简要总结
With improvements in detection and treatment of prostate cancer (PCa), more men than ever are living with side effects from PCa treatment; most distressingly, treatment side effects include problems with sexual functioning (e.g. erectile dysfunction, climacturia, inorgasmia). This study aims to develop a mindfulness-based group treatment for couples with sexual functioning complaints post-PCa treatment. Couples will be invited to a four-session mindfulness-based treatment group. Pre- and post-treatment outcomes (e.g., distress, sexual functioning/enjoyment, relationship satisfaction, treatment adherence) will assess feasibility and effectiveness of this novel treatment for couple's sexual lives after PCa.
详细描述
This is an intervention study designed to assess a novel mindfulness-based treatment protocol for couples dealing with sexual dysfunction secondary to prostate cancer treatment. Couples will be invited to participate through the Vancouver Prostate Centre (VPC) and the Prostate Cancer Survivorship Care (PCSC) Program. Interested couples will be screened for eligibility. Eligible couples will be randomized to either an immediate-start or a delayed-waitlist control group.
Prior to treatment, couples will complete an online questionnaire package. Treatment will consist of a 4-week mindfulness-based group lead by a clinician trained in mindfulness treatment. Sessions are 2hrs in length and take place in consecutive weeks, with daily homework recommended between sessions. The intervention was developed based on pre-existing mindfulness-based cognitive therapy treatment groups for sexual dysfunction developed by Dr. Lori Brotto at the UBC Sexual Health Laboratory, mindfulness in sex therapy and intimate relationships (MSIR) treatment group developed by Kocsis and Newbury-Helps (2016), and expert input. Sessions consist of mindfulness-based training, sex therapy techniques, and education. After treatment, couples will be invited to complete a post-treatment questionnaire once immediately after the end of treatment, and again 6 months later.
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
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently in a relationship that has lasted longer than 1 year
- •Both members of the couple are at least 19 years of age or older
- •Both members of the couple are able to speak and read English (to date, all of the treatment material is delivered in English)
- •(At least) one member of the couple has a history of prostate cancer diagnosis
- •The same member of the couple underwent radical prostatectomy for the treatment of his prostate cancer
- •Both members of the couple are willing and able to comply with all study procedures (including committing to daily homework over the 4-week period of the treatment program) and be available for the duration of the study
- •Both members of the couple provide signed and dated informed consent form
排除标准
- •The individual who was treated with prostate cancer received androgen deprivation therapy or radiation therapy to treat their prostate cancer.
- •Have a current health condition (e.g., severe cardiovascular health problems, unmanaged diabetes mellitus), physical disabilities, or mental health issues (e.g., severe anxiety, depression) that would interfere with self- or partnered-sexual activities, or the individual's ability to attend group sessions or complete home assignments
研究组 & 干预措施
Immediate start
Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment
干预措施: Mindfulness-based Therapy Group for Couples (Other)
Delayed start
Patients begin the Mindfulness-based Therapy Group for Couples after a delay post-study enrollment (approximately 6 months)
干预措施: Mindfulness-based Therapy Group for Couples (Other)
结局指标
主要结局
Sexual correlates: GMSEX
时间窗: Change from post-intervention (5 weeks) to 6-month follow up
GMSEX (Lawrance \& Byers, 1992). The GMSEX is a 5-item measure of distress related to sexual functioning with one's partner.
Sexual correlates: Self-reported sexual functioning
时间窗: Change from baseline to post-intervention (5 weeks)
Depending on sexual orientation and gender, individuals will complete either (1) International Index of Erectile Functioning (heterosexual men), International Index of Erectile Functioning for Men who have sex with men (gay men), or Female Sexual Functioning Index (female partners)
Sexual correlates: Self-reported erectile functioning
时间窗: Change from post-intervention (5 weeks) to 6-month follow up
Depending on sexual orientation and gender, individuals will complete either (1) International Index of Erectile Functioning (heterosexual men), International Index of Erectile Functioning for Men who have sex with men (gay men), or Female Sexual Functioning Index (female partners)
Sexual correlates: Sexual activity scale
时间窗: Change from post-intervention (5 weeks) to 6-month follow up
This is a questionnaire developed by the study lead that asks individual to rate the frequency of times that they engaged in a range of sexual activities over 3 time-periods: (a) ever, (b) since their/their partner's prostate cancer surgery, and (c) in the past 4 weeks.
Sexual correlates: Adapted dyadic adjustment scale
时间窗: Change from post-intervention (5 weeks) to 6-month follow up
Adapted dyadic adjustment scale (A-DAS; Sharpley \& Cross, 1982). The A-DAS is a validated, 7-item measure that assesses relationship adjustment.
次要结局
- mental and health-related quality of life indices: Hospital Anxiety and Depression Scale(Change from post-intervention (5 weeks) to 6-month follow up)
- mental and health-related quality of life indices: UCLA Prostate Cancer Index(Change from post-intervention (5 weeks) to 6-month follow up)