Testing an e-Health Intervention for Prostate Cancer Survivors' Mental and Sexual Health
NCT ID: NCT05946161
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-06-20
2024-08-01
Brief Summary
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Detailed Description
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Participants will be recruited at cancer units and will meet the inclusion criteria: prostate cancer survivors; 18 years old or older; ability to give informed consent; regular use of a smartphone and internet access; no other oncological diagnoses over the past five years, no severe neurological or psychological disorders. Participants will be randomly assigned to one of two conditions: 1) e-Health psychological intervention (N = 20); 2) waiting list group, N = 20). Participants will be clinically assessed before and after intervention on different psychosexual dimensions (e.g., mental health, quality of life, sexual dysfunction). By the end of the study, the waiting list group participants will be allowed to access the e-Health psychological intervention. 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, post-test, and 3-month follow-up assessments will be performed.
Main outcomes: psychological distress, sexual distress, sexual satisfaction, relational satisfaction, sexual dysfunctional beliefs, and quality of life. 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 user feedback.
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 attributing 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) thematic analysis to understand the user's experience (post-intervention interview)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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testing the digital intervention
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
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 guidance and support provided by a certified Clinical Psychologist, over a 6-week period.
waiting list
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
No interventions assigned to this group
Interventions
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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 guidance and support provided by a certified Clinical Psychologist, over a 6-week period.
Eligibility Criteria
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Inclusion Criteria
* 18 years old or older,
* Ability to give informed consent,
* Regular use of a smartphone and internet access.
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Horizon 2020 - European Commission
OTHER
Universidade do Porto
OTHER
Responsible Party
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Ana Luísa de Matos Dias Quinta Gomes
Assistant Researcher
Locations
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Faculty of Psychology and Educational Sciences
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NORTE-01-0145-FEDER-000057
Identifier Type: -
Identifier Source: org_study_id
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