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E-Mergir: A Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors (E-Mergir)

4 août 2026 mis à jour par: Ana Luísa de Matos Dias Quinta Gomes, Universidade do Porto

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

106

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Ana Luísa Quinta Gomes, PhD
  • Numéro de téléphone: +351965816335
  • E-mail: bisagomes@gmail.com

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Le Portugal
      • Porto, Le Portugal
        • Recrutement
        • Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: E-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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Global Measure of Sexual Satisfaction
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
International Index of Erectile Function
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidade do Porto

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 juillet 2027

Dates d'inscription aux études

Première soumission

18 mars 2026

Première soumission répondant aux critères de contrôle qualité

4 août 2026

Première publication (Réel)

10 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2023.05157.BD
  • NORTE-01-0145-FEDER-000057 (Autre subvention/numéro de financement: Horizon 2020 - European Commission)
  • UID/00050/2025 (Autre subvention/numéro de financement: Fundação para a Ciência e Tecnolo[Portuguese Foundation for Science and Technology])

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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