Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946161
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-06-23
Brief Title:
Testing an e-Health Intervention for Prostate Cancer Survivors Mental and Sexual Health
Sponsor:
Universidade do Porto
Organization:
Universidade do Porto
Study Overview
Official Title:
A Digital Intervention Program to Promote Mental and Sexual Health of Prostate Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 interventions efficacy
Detailed Description:
This study was approved by the Ethical Board of São João Hospital Porto 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 six weeks
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 eg 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 programs acceptability This study aims to inform a future a randomized control trial that aims to further test the e-Health interventions 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 users experience post-intervention interview
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 eg 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 programs acceptability This study aims to inform a future a randomized control trial that aims to further test the e-Health interventions 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 users experience post-intervention interview
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None