A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Miller Social Intimacy Scale (MSIS)
研究概览
简要总结
The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.
详细描述
Previous Research: The prevalence of sexual dysfunction (SD) after prostate cancer surgery, coupled with the severity of impact and lack of successful intervention, make SD one of the most substantial health-related quality of life burdens in all of cancer survivorship. In 2012, 21,000 men will be added to the pool of Canadian prostate cancer (PC) survivors. Approximately 70% of men will suffer SD post-surgery and 60% will experience significant distress in response to SD. Similarly, partners may experience even greater distress than patients. Research examining the nature of the distress reveals that the significance of SD extends beyond the ability to have an erection, and includes guilt, depression, anxiety, anger, and reductions in intimacy. Unfortunately, there are no reported interventions that have been successful in reducing the impact of SD on long term couple health-related quality of life.
Project Description: Men and their partners need an effective intervention to help them adapt to sexual dysfunction following prostate cancer surgery. In addressing this need we propose an innovative biomedical-psychosocial Intervention that emphasizes: 1) multidisciplinary intervention teams; 2) the active participation of the partner; and 3) a broad-spectrum medical, psychological, and social approach. The treatment goal of the intervention is to promote intimacy and optimal sexual health in affected couples. This is a preliminary study designed to determine the feasibility of running a large scale randomized controlled trial comparing the new biomedical-psychosocial intervention to an attention control condition.
Impact and Relevance: The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for a Radical Prostatectomy at the Princess Margaret Cancer Centre(open, laparoscopic, robotic) for the first-line treatment of prostate cancer regardless of clinical stage of disease
- •are hormone and/or chemotherapy-naïve
- •have a sexual partner (heterosexual or homosexual) for at least the past 6 months
- •are 18 years of age or older
- •Partners of men who meet the above criteria and are 18 years of age or older
排除标准
- •the patient or partner lacks English proficiency
- •the patient is on nitrate therapy or has other contra-indications to phosphodiesterase type 5 inhibitors (PDE5i's)
- •the patient does not have a sexual partner
- •the patient or partner has a medical condition that would preclude safe sexual activity
- •the patient has had previous treatment for PC
- •the patient has previously and regularly used sexual aids/devices during the course of sexual activity
研究组 & 干预措施
BSHR Intervention
Couples will attend 30-minute clinic consultations with an Urologist and a Sexual Health Counsellor and receive session-specific chapters of the Kindness, Intimacy, Sexuality and Satisfaction manual over the course of the intervention.
The BSHR Intervention involves two complementary components; the bio-medical, and the psychosocial. The bio-medical component for both arms intervention includes an urologist consultation at a pre-operative appointment and 5 f/u appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices.
The psychosocial component aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive sexual health counseling and manualized support.
干预措施: Biomedical Component (Behavioral)
BSHR Intervention
Couples will attend 30-minute clinic consultations with an Urologist and a Sexual Health Counsellor and receive session-specific chapters of the Kindness, Intimacy, Sexuality and Satisfaction manual over the course of the intervention.
The BSHR Intervention involves two complementary components; the bio-medical, and the psychosocial. The bio-medical component for both arms intervention includes an urologist consultation at a pre-operative appointment and 5 f/u appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices.
The psychosocial component aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive sexual health counseling and manualized support.
干预措施: Psychosocial Component (Behavioral)
Attention Control
Survivorship Counseling: Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) and receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: "Nutrition, Exercise, and You Manual". The bio-medical component is the same in both arms.
The core topics discussed during over 7 counseling sessions include: preparation for immediate post-surgery recovery, Kegel exercises, nutrition and prostate cancer, exercise and prostate cancer, and maintaining healthy lifestyle change.
干预措施: Biomedical Component (Behavioral)
Attention Control
Survivorship Counseling: Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) and receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: "Nutrition, Exercise, and You Manual". The bio-medical component is the same in both arms.
The core topics discussed during over 7 counseling sessions include: preparation for immediate post-surgery recovery, Kegel exercises, nutrition and prostate cancer, exercise and prostate cancer, and maintaining healthy lifestyle change.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Miller Social Intimacy Scale (MSIS)
时间窗: At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy
Miller Social Intimacy Scale (MSIS):MSIS is a 17-item measure of the maximum level of intimacy currently experienced is used in this study. Each question has a scale of 1-10 with a higher score representing higher level of intimacy.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)(13-14 months post-radical prostatectomy)
- Sexual Health Rehabilitation Record(3-4 months post-radical prostatectomy;7-8 months post-radical prostatectomy;12-13 months post-radical prostatectomy)
- International Index of Erectile Function (IIEF)(At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy)
- Female Sexual Function Inventory (FSFI)(At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy)
- Expanded Prostate Cancer Index Composite (EPIC)(At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy)