Prostate Cancer
Conditions
Keywords
prostate cancer, sexual health, mental health, e-Health, cognitive behavioral therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEE-Mergir
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.
Sponsors
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer survivors, * 18 years old or older, * Ability to give informed consent, * Regular use of a smartphone and internet access.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Measure of Sexual Satisfaction | 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 | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Questionnaire to assess erectile function |
| 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. | Questionnaire to assess relational satisfaction |
| 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. | Questionnaire to assess sexual dysfunctional beliefs |
| 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. | A subscale of this questionnaire will be used to assess automatic thoughts |
| 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. | As an exploratory outcome we will use this questionnaire to assess post-traumatic growth |
Countries
Portugal
Contacts
CONTACTAna Luísa Quinta Gomes, PhD
CONTACTSonia Pieramico, MSc
Outcome results
None listed