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

NCT05946161 | Recruiting

• 1 other identifier: NORTE-01-0145-FEDER-000057
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

e-Health; cognitive behavioral therapy; prostate cancer; sexual health; mental health

Outcome Measures

Primary Outcomes (6)

• Brief Symptom Inventory

  Questionnaire to assess psychological distress

  Change from baseline psychological distress at final program (6 weeks)

• Sexual Distress Scale

  Questionnaire to assess sexual distress

  Change from baseline sexual distress at final program (6 weeks)

• WHOQoL-BREF

  Questionnaire to assess quality of life

  Change from baseline quality of life at final program (6 weeks)

• Global Measure of Sexual Satisfaction

  Questionnaire to assess sexual satisfaction

  Change from baseline sexual satisfaction at final program (6 weeks)

• Global Measure of Relationship Satisfaction

  Questionnaire to assess relationship satisfaction

  Change from baseline relationship satisfaction at final program (6 weeks)

• System Usability Scale

  Questionnaire to assess acceptability and usability

  Post assessment - through study completation, (6 weeks)

Secondary Outcomes (2)

• International Index of Erectile Function

  Change from baseline sexual function at final program (6 weeks)

• Dysfunctional Sexual Beliefs Questionnaire

  Change from baseline dysfunctional sexual beliefs at final program (6 weeks)

Study Arms (2)

testing the digital intervention

EXPERIMENTAL

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

Behavioral: e-Health intervention to promote mental and sexual health of prostate cancer survivors

waiting list

NO INTERVENTION

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

Interventions

e-Health intervention to promote mental and sexual health of prostate cancer survivors BEHAVIORAL

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.

testing the digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer survivors,
• years old or older,
• Ability to give informed consent,
• Regular use of a smartphone and internet access.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Faculty of Psychology and Educational Sciences

Porto, 4200-135, Portugal

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Ana Luisa Quinta Gomes, PhD

CONTACT

+351965816335; anagomes@fpce.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 14, 2023
• Study Start: June 20, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 1, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)