Prostate Cancer Clinical Trial
Official title:
A Digital Intervention Program to Promote Mental and Sexual Health of Prostate Cancer Survivors
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 1, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Faculty of Psychology and Educational Sciences | Porto |
Lead Sponsor | Collaborator |
---|---|
Universidade do Porto | Horizon 2020 - European Commission |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brief Symptom Inventory | Questionnaire to assess psychological distress | Change from baseline psychological distress at final program (6 weeks) | |
Primary | Sexual Distress Scale | Questionnaire to assess sexual distress | Change from baseline sexual distress at final program (6 weeks) | |
Primary | WHOQoL-BREF | Questionnaire to assess quality of life | Change from baseline quality of life at final program (6 weeks) | |
Primary | Global Measure of Sexual Satisfaction | Questionnaire to assess sexual satisfaction | Change from baseline sexual satisfaction at final program (6 weeks) | |
Primary | Global Measure of Relationship Satisfaction | Questionnaire to assess relationship satisfaction | Change from baseline relationship satisfaction at final program (6 weeks) | |
Primary | System Usability Scale | Questionnaire to assess acceptability and usability | Post assessment - through study completation, (6 weeks) | |
Secondary | International Index of Erectile Function | Questionnaire to assess sexual function | Change from baseline sexual function at final program (6 weeks) | |
Secondary | Dysfunctional Sexual Beliefs Questionnaire | Questionnaire to assess dysfunctional sexual beliefs | Change from baseline dysfunctional sexual beliefs at final program (6 weeks) |
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