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Testing an e-Health Intervention for Prostate Cancer Survivors' Mental and Sexual Health

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
e-Health intervention to promote mental and sexual health of prostate cancer survivors
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring e-Health, cognitive behavioral therapy, prostate cancer, sexual health, mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Psychology and Educational SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

testing the digital intervention

waiting list

Arm 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

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

Outcomes

Primary Outcome Measures

Brief Symptom Inventory
Questionnaire to assess psychological distress
Sexual Distress Scale
Questionnaire to assess sexual distress
WHOQoL-BREF
Questionnaire to assess quality of life
Global Measure of Sexual Satisfaction
Questionnaire to assess sexual satisfaction
Global Measure of Relationship Satisfaction
Questionnaire to assess relationship satisfaction
System Usability Scale
Questionnaire to assess acceptability and usability

Secondary Outcome Measures

International Index of Erectile Function
Questionnaire to assess sexual function
Dysfunctional Sexual Beliefs Questionnaire
Questionnaire to assess dysfunctional sexual beliefs

Full Information

First Posted
June 23, 2023
Last Updated
August 28, 2023
Sponsor
Universidade do Porto
Collaborators
Horizon 2020 - European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT05946161
Brief Title
Testing an e-Health Intervention for Prostate Cancer Survivors' Mental and Sexual Health
Official Title
A Digital Intervention Program to Promote Mental and Sexual Health of Prostate Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
Collaborators
Horizon 2020 - European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 intervention's 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 (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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
e-Health, cognitive behavioral therapy, prostate cancer, sexual health, mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
testing the digital intervention
Arm Type
Experimental
Arm 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
Arm Title
waiting list
Arm Type
No Intervention
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
e-Health intervention to promote mental and sexual health of prostate cancer survivors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Symptom Inventory
Description
Questionnaire to assess psychological distress
Time Frame
Change from baseline psychological distress at final program (6 weeks)
Title
Sexual Distress Scale
Description
Questionnaire to assess sexual distress
Time Frame
Change from baseline sexual distress at final program (6 weeks)
Title
WHOQoL-BREF
Description
Questionnaire to assess quality of life
Time Frame
Change from baseline quality of life at final program (6 weeks)
Title
Global Measure of Sexual Satisfaction
Description
Questionnaire to assess sexual satisfaction
Time Frame
Change from baseline sexual satisfaction at final program (6 weeks)
Title
Global Measure of Relationship Satisfaction
Description
Questionnaire to assess relationship satisfaction
Time Frame
Change from baseline relationship satisfaction at final program (6 weeks)
Title
System Usability Scale
Description
Questionnaire to assess acceptability and usability
Time Frame
Post assessment - through study completation, (6 weeks)
Secondary Outcome Measure Information:
Title
International Index of Erectile Function
Description
Questionnaire to assess sexual function
Time Frame
Change from baseline sexual function at final program (6 weeks)
Title
Dysfunctional Sexual Beliefs Questionnaire
Description
Questionnaire to assess dysfunctional sexual beliefs
Time Frame
Change from baseline dysfunctional sexual beliefs at final program (6 weeks)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Luisa Quinta Gomes, PhD
Phone
+351965816335
Email
anagomes@fpce.up.pt
Facility Information:
Facility Name
Faculty of Psychology and Educational Sciences
City
Porto
ZIP/Postal Code
4200-135
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Luisa Quinta Gomes, PhD
Phone
+351965816335
Email
anagomes@fpce.up.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Testing an e-Health Intervention for Prostate Cancer Survivors' Mental and Sexual Health

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