Clinical trial · Interventional
Testing an e-Health Intervention for Prostate Cancer Survivors' Mental and Sexual Health
A Digital Intervention Program to Promote Mental and Sexual Health of Prostate Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to assess the acceptability, feasibility, and preliminary efficacy of an e-Health psychological intervention specifically designed to promote sexual health, mental health, and general well-being and quality of life in men with prostate cancer. A pilot study will be conducted involving prostate cancer survivors randomly assigned to one of two conditions: the experimental group (receiving the program) vs the control condition (waiting list). The experimental group is expected to improve on outcomes related to mental and sexual well-being when compared to the control group. Furthermore, the experimental group is expected to show good acceptability of the intervention program. This study aims to inform the design and methodology to be adopted in a future randomized controlled trial aimed to further test the e-Health intervention's efficacy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| e-Health intervention to promote mental and sexual health of prostate cancer survivors | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- testing the digital intervention
- description
- Prostate cancer survivors (n=20) 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 and Post testing involve questionnaires collecting data on psychosexual variables. At post-testing a 30-minute interview will be conducted to collect information on the usability
- interventionNames
- Behavioral: e-Health intervention to promote mental and sexual health of prostate cancer survivors
- type
- NO_INTERVENTION
- label
- waiting list
- description
- Prostate cancer survivors (n=20) randomly assigned to this arm will not be accompanied or get access to the intervention during the six week period in which the experimental group is completing the intervention. Pre and Post testing involved questionnaires collecting data on psychosexual variables. After post testing the control arm will gain access to the intervention as compensation for their participation
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available