Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06877598

Conditions

Prostate Cancer

Sexual Dysfunction, Physiological

Sexual Dysfunction, Psychological

Sexual Dysfunction

Virtual Care

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to evaluate the effectiveness of SHAReClinic, a national, virtual Sexual Health and Rehabilitation eClinic designed to support prostate cancer patients and their partners. Specifically, this study aims to assess SHAReClinic's impact on improving sexual function, satisfaction, and relational intimacy after treatment.

The primary objective is to evaluate SHAReClinic's effectiveness across participating sites and determine its role in supporting long-term sexual health and well-being.

As part of usual care, newly enrolled SHAReClinic patients will receive guided education modules and access to sexual health counselling at key recovery milestones.

SHAReClinic seeks to expand access to sexual health care for prostate cancer patients across Canada by providing evidence-based, virtual sexual rehabilitation. Findings from this study will inform best practices in survivorship care and contribute to the development of a national standard for oncology sexual health interventions.

Conditions

Prostate Cancer

Sexual Dysfunction, Physiological

Sexual Dysfunction, Psychological

Sexual Dysfunction

Virtual Care

Study ID

NCT06877598

Start date

Jun 1, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients who are scheduled for first-line treatment for localized prostate cancer, either through radical prostatectomy (open or robotic) or radiation treatment (brachytherapy, external beam) Alone, or with adjuvant Androgen Deprivation Therapy (ADT) OR

  • Patients currently undergoing active treatment for prostate cancer OR
  • Patients who have undergone cancer treatment in the past 6 months
  • Patients who are hormone and/or chemotherapy-naïve
  • Patients who have access to a computer or smartphone with internet access
  • Patients who are 18 years of age or older

Exclusion Criteria:

  • Patients on ADT alone as primary treatment, and/or patients on chemotherapy
  • Patients who lack English proficiency
  • Patients on nitrate therapy or have other contra-indications to phosphodiesterase type 5 inhibitors (PDE5i's)
  • Patients with medical conditions that would preclude safe sexual activity
  • Patients who have had previous treatment for PCa

Study Design

Enrollment

575 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Assessing SHAReClinic's Impact on Sexual Function and Satisfaction [ Time Frame: Baseline, 6 weeks, 6 months, and 12 months ]
  • Assessing SHAReClinic's Impact on Sexual Distress [ Time Frame: Baseline, 6 weeks, 6 months, and 12 months ]
  • Assessing SHAReClinic's Impact on Relational Intimacy [ Time Frame: Baseline, 6 weeks, 6 months, and 12 months ]
  • Assessing SHAReClinic's Impact on Health-Related Quality of Life [ Time Frame: Baseline, 6 weeks, 6 months, and 12 months ]
  • Overall Patient Satisfaction with SHAReClinic [ Time Frame: Final clinic visit (12 months) ]

Central Contacts and Locations

Central contacts

Locations

Vancouver Coastal Health Authority

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Principal Investigator:

Celestia Higano

Men's Health Clinic Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3K 1M3

Contacts

Principal Investigator:

Premal Patel

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Principal Investigator:

Julia Brown

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Principal Investigator:

Jessica Bonney

Grass Family Men's Health Center

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Principal Investigator:

Luke Witherspoon

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

Contacts

Principal Investigator:

Andrew Matthew

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • Sexual Dysfunction
  • Prostate cancer
  • Virtual health
  • Implementation
  • Consolidated Framework for Implementation Research (CFIR)
  • Bio-psychosocial
  • Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM)
  • Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-11.