About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
System-Level Evaluation: Enrolment, Attrition, and Adherence Rates
This objective evaluates the feasibility and sustainability of SHAReClinic by analyzing recruitment, retention, and adherence trends. How This Is Measured: Enrolment rates → Number of patients registering for SHAReClinic at each site. Attrition rates → Number of patients who discontinue SHAReClinic participation before completing the full program. Adherence rates → Number of patients who complete all scheduled clinic visits (6 total) within the 12-month follow-up.
Evaluating Patient Interest and Acceptance of SHAReClinic
SHAReClinic's success depends on its acceptability and usability among prostate cancer survivors. How This Is Measured: Recruitment Interest → Tracked by number of patients who register for SHAReClinic upon referral. Patient Acceptance (Attrition Analysis) → Measured through dropout rates, patient-reported reasons for withdrawal, and qualitative feedback.
Data Completeness and Quality
Ensuring that all patient-reported data is collected and available for analysis. How This Is Measured: Clinic visit completeness → Percentage of patients who complete six months/one year clinic visits. Data completeness → Percentage of patients who submit all required PROMIS SexFS, EPIC-26, SDS, and MSIS questionnaires. Integrity of data collection → Tracked by missing or incomplete responses. Comparison of data consistency across sites → Evaluates whether data is collected uniformly across all 11 cancer centers.
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