E-Mergir: a Randomized Controlled Trial to Test the Efficacy of a Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Global Measure of Sexual Satisfaction
研究概览
简要总结
Prostate cancer (PCa) survivors frequently experience enduring psychosexual challenges following treatment, including sexual dysfunction, emotional distress, and reduced quality of life. Despite these difficulties, access to tailored support remains limited, highlighting the need for scalable and accessible alternatives such as digital interventions. This study presents the protocol for a randomized controlled trial (RCT) evaluating the effectiveness of E-Mergir, a digital psychosexual intervention developed for PCa survivors. Grounded in cognitive behavioral therapy (CBT) and mindfulness strategies, the intervention aims to enhance both sexual and mental well-being. The trial employs a wait-list control design with randomized allocation. Participants will complete assessments at baseline, post-intervention, and follow-up, using validated measures related to sexual outcomes (sexual satisfaction, pleasure, function, distress, and beliefs) and mental health outcomes (quality of life, anxiety, depression, mindfulness, relationship satisfaction, and automatic thoughts). The study aims to determine whether E-Mergir is an effective digital intervention for improving psychosexual outcomes in PCa survivors, compared to a wait-list control group. It also aims to examine treatment predictors to illustrate the mechanisms through which improvements in mental and sexual health are achieved. If effective, E-Mergir could address a critical gap in supportive care for PCa survivors and serve as a model for culturally tailored digital psychosexual interventions globally.
详细描述
This study was approved by the Ethical Board of Coimbra University Hospital. An online psychological intervention (e-Health app technology) specifically tailored to meet the needs of Portuguese men with prostate cancer was developed to promote participants' mental and sexual health. The intervention protocol was designed under Cognitive-Behavior Therapy (CBT) principles, featuring psychological and sexual health promotion strategies. The intervention program consists of 5 modules covering components of psychoeducation, sexual rehabilitation, mindfulness, cognitive restructuring, and relapse prevention. The modules will be delivered online (using text, videos, and graphics) along with therapeutic guidance and support provided by a certified Clinical Psychologist over eight weeks.
Participants will be recruited through medical doctors at the Urology department of Coimbra University Hospital and invited telephonically to participate in the present study. If the potential participant declares interest, a researcher will contact them telephonically to confirm the following inclusion criteria: i) bein a prostate cancer survivor; ii) 18 years old or older; iii) have the ability to give informed consent; iv) own a smartphone and have internet access; v) no other oncological diagnoses over the past five years, vi)no severe neurological or psychological disorders.
Participants will be randomly assigned to one of two conditions: 1) e-Health psychological intervention (n=53); 2) waiting list group, (n= 53). Participants will be clinically assessed before and after the intervention on different psychosexual dimensions (e.g., mental health, quality of life, sexual dysfunction). The experimental group is expected to improve regarding mental and sexual well-being outcomes compared to the control group. Furthermore, the experimental group is expected to show the program's acceptability. This study aims to inform a future a randomized control trial that aims to further test the e-Health intervention's efficacy. Pre, mid-term, (at 4 weeks) post-test, three-month and six-month follow-up assessments will be performed for both groups.
Primary outcomes: psychological distress, sexual distress, sexual satisfaction, sexual pleasure, mindfulness, and quality of life.
Secondary outcomes: Sexual function, relational satisfaction, sexual dysfunctional beliefs, and automatic thoughts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer survivors,
- •18 years old or older,
- •Ability to give informed consent,
- •Regular use of a smartphone and internet access.
排除标准
- •Other diagnosed oncological diseases over the past five years,
- •Severe neurological impairment or other severe psychological/psychiatric diseases (depression, generalized anxiety disorder, psychosis-related disorders),
- •Other uncontrolled/unstable diseases,
- •Severe hearing and/or visual impairment,
- •Under psychotherapy or treatment for sexual problems,
- •Participating concurrently in other clinical trials.
研究组 & 干预措施
Experimental: testing the digital intervention
Experimental: testing the digital intervention. Prostate cancer survivors (n=53) randomly assigned to this arm will complete a digital psychosexual intervention and will be accompanied weekly by a certified clinical psychologist to monitor progress (synchronous or asynchronous). Pre- midterm (4 weeks into intervention) and post testing involve questionnaires collecting data on psychosexual variables. At post-testing a 30-minute interview will be conducted to collect information on how possible mental and sexual health improvements were achieved.
干预措施: E-Mergir (Device)
Waiting list group: waiting to access the intervention after an eight-week waiting period.
Waiting list group: waiting to access the intervention after an eight-week waiting period. Prostate cancer survivors (n=53) randomly assigned to this arm will not be accompanied or get access to the intervention during the eight week period in which the experimental group is completing the intervention. Pre- midterm and post testing involve questionnaires collecting data on psychosexual variables. After post testing the waiting-list arm will gain access to the intervention.
结局指标
主要结局
Global Measure of Sexual Satisfaction
时间窗: Change from baseline sexual satisfaction over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.
Questionnaire to assess sexual satisfaction
Sexual Pleasure Scale
时间窗: Change from baseline sexual pleasure over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.
Questionnaire to assess sexual pleasure
Female Sexual Distress Scale-Revised
时间窗: Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.
Questionnaire to assess sexual distress
The World Health Organization Quality of Life - Brief Version
时间窗: Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.
Questionnaire to assess general quality of life
The Brief Symptom Inventory
时间窗: Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.
Questionnaire to assess psychological distress
The Five Facet Mindfulness Questionnaire
时间窗: Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.
Questionnaire to assess ability for mindfulness
次要结局
- International Index of Erectile Function(Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.)
- Global Measure of Relational Satisfaction(Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.)
- The Sexual Dysfunctional Beliefs Questionnaire(Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.)
- Sexual Modes Questionnaire(Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.)
- Posttraumatic Growth Inventory(Change from baseline over midterm assessment at 4 weeks of intervention, at 8 weeks (post-test), and at 3 and 6 months after study completion.)
研究者
Ana Luísa de Matos Dias Quinta Gomes
Professor
Universidade do Porto