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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ana Luísa Quinta Gomes, PhD
- 電話番号：+351965816335
- メール：bisagomes@gmail.com
研究連絡先のバックアップ
- 名前：Sonia Pieramico, MSc
- メール：soniapieramico@gmail.com
研究場所
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Porto、ポルトガル
- 募集
- Faculdade de Psicologia e de Ciências da Educação da Universidade do Porto
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コンタクト：
- Ana Gomes
- メール：bisagomes@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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|
介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Global Measure of Sexual Satisfaction
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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International Index of Erectile Function
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2023.05157.BD
- NORTE-01-0145-FEDER-000057 (その他の助成金/資金番号：Horizon 2020 - European Commission)
- UID/00050/2025 (その他の助成金/資金番号：Fundação para a Ciência e Tecnolo[Portuguese Foundation for Science and Technology])
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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