E-Mergir: A Digital Psychosexual Intervention for the Promotion of Mental and Sexual Health of Prostate Cancer Survivors (E-Mergir)
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
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ana Luísa Quinta Gomes, PhD
- Número de telefone: +351965816335
- E-mail: bisagomes@gmail.com
Estude backup de contato
- Nome: Sonia Pieramico, MSc
- E-mail: soniapieramico@gmail.com
Locais de estudo
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Porto, Portugal
- Recrutamento
- Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
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Contato:
- Ana Gomes
- E-mail: bisagomes@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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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.
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Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Global Measure of Sexual Satisfaction
Prazo: 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.
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Questionnaire to assess sexual satisfaction
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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.
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Sexual Pleasure Scale
Prazo: 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.
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Questionnaire to assess sexual pleasure
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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.
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Female Sexual Distress Scale-Revised
Prazo: 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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Questionnaire to assess sexual distress
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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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The World Health Organization Quality of Life - Brief Version
Prazo: 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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Questionnaire to assess general quality of life
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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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The Brief Symptom Inventory
Prazo: 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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Questionnaire to assess psychological distress
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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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The Five Facet Mindfulness Questionnaire
Prazo: 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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Questionnaire to assess ability for mindfulness
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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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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International Index of Erectile Function
Prazo: 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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Questionnaire to assess erectile function
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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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Global Measure of Relational Satisfaction
Prazo: 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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Questionnaire to assess relational satisfaction
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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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The Sexual Dysfunctional Beliefs Questionnaire
Prazo: 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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Questionnaire to assess sexual dysfunctional beliefs
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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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Sexual Modes Questionnaire
Prazo: 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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A subscale of this questionnaire will be used to assess automatic thoughts
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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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Posttraumatic Growth Inventory
Prazo: 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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As an exploratory outcome we will use this questionnaire to assess post-traumatic growth
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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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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Bossio JA, Miller F, O'Loughlin JI, Brotto LA. Sexual Health Recovery For Prostate Cancer Survivors: The Proposed Role Of Acceptance And Mindfulness-Based Interventions. Sex Med Rev. 2019 Oct;7(4):627-635. doi: 10.1016/j.sxmr.2019.03.001. Epub 2019 Apr 24.
- Pieramico, S., Rocha, H., & Quinta-Gomes, A. L. (2025). E-MERGIR: a QUALITATIVE STUDY ON ACCEPTABILITY AND USABILITY OF a DIGITAL PSYCHOSEXUAL INTERVENTION FOR PROSTATE CANCER SURVIVORS. The Journal of Sexual Medicine, 22(Supplement_2). https://doi.org/10.1093/jsxmed/qdaf077.132
- Siddons HM, Wootten AC, Costello AJ. A randomised, wait-list controlled trial: evaluation of a cognitive-behavioural group intervention on psycho-sexual adjustment for men with localised prostate cancer. Psychooncology. 2013 Oct;22(10):2186-92. doi: 10.1002/pon.3273. Epub 2013 Apr 10.
- Pieramico S, Castro R, Aguiar S, Bismarck F, Ferreira D, Carvalho J, Quinta Gomes AL, Nobre P. A systematic review on the efficacy of CBT interventions for the mental and sexual health of survivors of prostate cancer. Sex Med Rev. 2023 Dec 23;12(1):48-58. doi: 10.1093/sxmrev/qead024.
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- 2023.05157.BD
- NORTE-01-0145-FEDER-000057 (Número de outro subsídio/financiamento: Horizon 2020 - European Commission)
- UID/00050/2025 (Número de outro subsídio/financiamento: Fundação para a Ciência e Tecnolo[Portuguese Foundation for Science and Technology])
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