An interventional study of E-Mergir in Prostate Cancer, sponsored by Universidade do Porto. Recruiting at 1 site in Portugal. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment
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.
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.
Exploratory outcomes: post-traumatic growth All scales are validated and adapted to the Portuguese population. Furthermore, a semi-structured interview will be conducted with experimental group participants by the end of the study to collect further insight on how possible mental and sexual improvements were achieved.
Participants' data will be stored in an encrypted file, saved on a computer, and only accessible to the main researchers of this study. Confidentiality will be guaranteed by assigning an individual code to each participant. This code will be used to log into the digital intervention and complete psychometric scales. Interviews will be recorded and transcribed. Transcriptions will be marked with the same code to ensure the association of the collected data.
Statistical procedures will be performed using IBM SPSS and include i) descriptive analyses; ii) MANOVA to measure differences among groups and to compare assessment moments; iii) Multiple Regression Analysis to examine treatment predictors; iv) Structural Equation Modeling to illustrate the mechanisms by which improvement of mental and sexual health was achieved.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 106 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Universidade do Porto is the lead sponsor of 174 studies on the registry; 53 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: E-Mergir
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.
e-Health intervention to promote mental and sexual health of prostate cancer survivors. 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 the principles of Cognitive Behavior Therapy (CBT), 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 support provided by a certified Clinical Psychologist, over an eight-week period.
Global Measure of Sexual Satisfaction
Questionnaire to assess sexual satisfaction
Time frame: 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.
Sexual Pleasure Scale
Questionnaire to assess sexual pleasure
Time frame: 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.
Female Sexual Distress Scale-Revised
Questionnaire to assess sexual distress
Time frame: 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 World Health Organization Quality of Life - Brief Version
Questionnaire to assess general quality of life
Time frame: 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 Brief Symptom Inventory
Questionnaire to assess psychological distress
Time frame: 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 Five Facet Mindfulness Questionnaire
Questionnaire to assess ability for mindfulness
Time frame: 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.
International Index of Erectile Function
Questionnaire to assess erectile function
Time frame: 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
Questionnaire to assess relational satisfaction
Time frame: 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
Questionnaire to assess sexual dysfunctional beliefs
Time frame: 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
A subscale of this questionnaire will be used to assess automatic thoughts
Time frame: 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
As an exploratory outcome we will use this questionnaire to assess post-traumatic growth
Time frame: 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.
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