Canada-wide Implementation of a Virtual Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners

NCT06877598 | Recruiting

• 1 other identifier: 708251
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 10

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

Sexual Dysfunction, Physiological; Virtual Clinic; Survivorship; Implementation; Prostate Cancer; Sexual Dysfunction, Psychological; Sexual Dysfunction; Virtual Care; Implementation of Evidence Based Programs

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

Outcome Measures

Primary Outcomes (5)

• Assessing SHAReClinic's Impact on Sexual Function and Satisfaction

  Measured using: PROMIS-20 Full Profile Sexual Function and Satisfaction (Male) This outcome assesses sexual function and satisfaction across multiple domains, including erectile function, orgasm, and overall sexual activity. Each item is scored on a 5-point Likert scale, and raw scores are converted to T-scores (Mean = 50, SD = 10). A higher T-score indicates better sexual function and satisfaction. The measure is collected at multiple time points to track changes in sexual function over time.

  Baseline, 6 weeks, 6 months, and 12 months

• Assessing SHAReClinic's Impact on Sexual Distress

  Measured using: Sexual Distress Scale (SDS - Male) This outcome measures the level of distress related to sexual function, including anxiety and emotional responses to changes in sexual activity post-treatment. Items are rated on a 5-point scale, and total scores are summed. A higher score indicates greater sexual distress, meaning that patients experiencing more distress will have higher numerical values. This outcome is assessed periodically to evaluate changes over time.

  Baseline, 6 weeks, 6 months, and 12 months

• Assessing SHAReClinic's Impact on Relational Intimacy

  Measured using: Miller Social Intimacy Scale (MSIS) This outcome evaluates emotional and physical intimacy between partners. The scale measures the frequency and intensity of intimate interactions, providing insight into relationship closeness post-treatment. Items are rated on a 10-point scale, with total scores summed to create an overall intimacy score. Higher scores indicate greater relational intimacy. This measure helps determine how SHAReClinic interventions impact the intimacy of participants and their partners.

  Baseline, 6 weeks, 6 months, and 12 months

• Assessing SHAReClinic's Impact on Health-Related Quality of Life

  Measured using: Expanded Prostate Index Composite Short Form (EPIC-26) This outcome assesses multiple domains of health-related quality of life, including urinary, bowel, sexual, and hormonal function. Scores for each domain are transformed linearly to a 0-100 scale, where higher scores indicate better quality of life in that domain. The EPIC-26 allows for a comprehensive evaluation of how SHAReClinic impacts sexual health and broader survivorship concerns.

  Baseline, 6 weeks, 6 months, and 12 months

• Overall Patient Satisfaction with SHAReClinic

  Measured using: SHAReClinic Satisfaction Questionnaire This outcome measures participant satisfaction with the SHAReClinic platform and its interventions. Patients rate their satisfaction with various aspects of the program, including ease of access, quality of resources, and effectiveness of support services. Items are scored on a 5-point Likert scale, where higher scores indicate greater satisfaction. This measure is collected at the end of the study to assess the overall user experience.

  Final clinic visit (12 months)

Secondary Outcomes (3)

• System-Level Evaluation: Enrolment, Attrition, and Adherence Rates

  From enrollment to the end of 1st year on SHAReClinic

• Evaluating Patient Interest and Acceptance of SHAReClinic

  From enrollment to the end of 1st year on SHAReClinic

• Data Completeness and Quality

  From enrollment to the end of 1st year on SHAReClinic

Eligibility Criteria

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

Study Population

The study population will consist of newly enrolled SHAReClinic patients across the 11 participating cancer centers. These participants will be prostate cancer patients who are either about to start, currently undergoing, or have recently completed treatment. The study will assess their experiences and outcomes as they engage with SHAReClinic as part of their usual care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (10)

Vancouver Coastal Health Authority

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

RECRUITING

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

Dianne & Irving Kipnes Urology Centre

Edmonton, Ontario, T6G 1Z1, Canada

NOT YET RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

NOT YET RECRUITING

Trillium Health Partners

Mississauga, Ontario, L5A 4G1, Canada

NOT YET RECRUITING

Grass Family Men's Health Center

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Study Officials

• Andrew Matthew, PhD. C.Psych

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Guirguis, MA

CONTACT

416-946-4501; steven.guirguis@uhn.ca

SHC Clinic

CONTACT

416-946-4501; SHC@uhn.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)