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Prostate CancerNCT06877598

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

An observational study of Prostate Cancer and Sexual Dysfunction, Physiological, run by University Health Network, Toronto at 10 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
575 participants
Where
10 sitesCanada
Study dates
1 Jun 2025to Dec 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

10 sites in 1 country

Canada10 sites, 10 recruiting
  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Lindsey Huff, 705-728-9090 ext. 43327, HuffL@rvh.on.ca

    Julia Brown

    Recruiting
  • Dianne & Irving Kipnes Urology Centre

    Edmonton, Ontario, T6G 1Z1

    Sarah Rayner-Myers, 825-963-6459, Sarah.Rayner-Myers@albertahealthservices.ca

    Phil Bach

    Not yet recruiting
  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Debora Stark, 613-544-2631 ext. 6737, debora.stark@kingstonhsc.ca

    Jessica Bonney

    Recruiting
  • St. Joseph's Health Care London

    London, Ontario, N6A 4V2

    Mary McKibbon, 519-646-6100 ext. 65308, Mary.McKibbon@sjhc.london.on.ca

    Jeffrey Campbell

    Not yet recruiting
  • Trillium Health Partners

    Mississauga, Ontario, L5A 4G1

    Andrew Feifer

    Not yet recruiting
  • Grass Family Men's Health Center

    Ottawa, Ontario, K1Y 4E9

    Amanda Ross, 613-798-5555 ext. 19641, amanross@toh.ca

    Luke Witherspoon

    Recruiting
  • St. Paul's Hospital

    Saskatoon, Saskatchewan, S7M 0Z9

    Jennifer Bond, 306.655.6039, Jennifer.Bond@saskhealthauthority.ca

    Trustin Domes

    Not yet recruiting
  • University Health Network

    Toronto, Ontario, M5G 1Z5

    Steven Guirguis, 416-946-4501 ext. 2598, steven.guirguis@uhn.ca

    Andrew Matthew

    Recruiting
  • Vancouver Coastal Health Authority

    Vancouver, British Columbia, V5Z 1M9

    Monita Sundar, (604) 875-4111 ext. 22946, Monita.Sundar@vch.ca

    Celestia Higano

    Recruiting
  • Men's Health Clinic Manitoba

    Winnipeg, Manitoba, R3K 1M3

    Avinash Sarcar, 204-221-4476, asarcar.mhc@gmail.com

    Premal Patel

    Recruiting

Other trials in Canada

About this study

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.

Read more

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.

Read the detailed description

Detailed Description The considerable prevalence of sexual dysfunction (SD) after prostate cancer (PCa) treatment makes SD post-treatment a substantial health-related quality of life burden for patients and their partners. Research indicates that 40% to 75% of men suffer from SD post-PCa. Sixty percent of men experience significant distress in response to SD. Significant distress is also reported by partners and couples. Overall, patients cite sexual health concerns as the most significant unmet need following treatment for PCa. Accordingly, there is an existent need for equitable, timely, and affordable access to high-quality SD treatment for Canadian PCa patients and their partners.

Unfortunately, none of the empirically-based, comprehensive interventions reported in the literature have been implemented into clinical settings in Canada. The lack of translation from research evidence to clinical implementation is common across healthcare provision. It is known that most research, even positive full-scale studies, do not result in practice-change or take years to do so. A key aspect contributing to this lack of knowledge translation is the complexity of transitioning an "experimental intervention" to "real world" clinical settings. In sexual healthcare in oncology, ineffective knowledge translation is ubiquitous and includes several unique complexities that impair the implementation, integration, and sustainability of empirically-based treatment.

The recent advent of virtual care in healthcare offers an opportunity to address many of the barriers to implementing sexual recovery programs within PCa treatment facilities. Virtual care provides greater accessibility for patients not proximal to cancer centres, or who are unable to travel due to financial constraints or physical limitations. Encouragingly, examples of internet-delivered interventions exist for men with PCa and their partners. Schover and colleagues found that a digitally-based intimacy enhancement intervention was as effective as a brief in-person sex therapy intervention in improving sexual outcomes in couples after PCa. Although these advances in models of care provision are inspiring, the majority of Canadian PCa patients and their partners have yet to benefit from virtual care innovations.

In an effort to advance evidence-based survivorship programming in the treatment of SD post-PC, a team of expert Canadian healthcare practitioners and patient/partner advocates developed the Sexual Health and Rehabilitation eClinic (SHAReClinic). SHAReClinic is a web-based, bio-psychosocial SD intervention specifically for patients/couples who have undergone treatment for PCa. A pilot study evaluating the acceptability and engagement of SHAReClinic achieved significant patient activity on the platform and 80% patient engagement at 1-year follow-up. Additionally, evaluation of the effectiveness of SHAReClinic showed non-inferior sexual health outcomes when compared to a "best practice" in-person sexual health clinic.

Rationale Sexual dysfunction after PCa treatment has significant adverse impacts on patient/partner health-related quality of life. Few Cancer Centres in Canada offer comprehensive care for SD post-PCa treatment, resulting in significant barriers to care equity and access. SHAReClinic is established as effective virtual care programming for SD post-PCa.

The goal of this research is to evaluate the SHAReClinic in 2 cancer centres currently using it as usual care and 9 cancer centres which has newly implemented SHAReClinic as part of their usual care. The SHAReClinic will be offered to 1. Newly diagnosed patients at who are scheduled to undergo active treatment for localized prostate cancer, 2. patients currently undergoing active treatment for prostate cancer and 3. patients who have undergone prostate cancer treatment within the last 6 months. Active treatment can include any of the following options surgical, radiation, and/or ADT. The SHAReClinic goals are to re-establish optimal sexual function, satisfaction and to support the maintenance of intimacy following prostate cancer treatment. These goals are addressed through two complementary components: 1) a bio-medical component (erectile rehabilitation), focused on the long term penile health or short-term erectile function as per patient preference, and 2) a psychological component (intimacy maintenance), involving the maintenance or restoration of couples' intimacy and sexual activity (penetrative or non-penetrative). Both physical and psychological factors can affect patients' sexual satisfaction after cancer treatment; resultantly, interventions should incorporate a bio-psychosocial approach to rehabilitation.

Study Design This is a prospective observational evaluation of a virtual sexual health and rehabilitation intervention program. As part of patient standard care, facilitated web-based clinic visits will be provided to patients once before treatment, 6 weeks, 10 weeks, 4 months, 6 months and 12 months post cancer treatment. Patients who opt-in to the SHAReClinic will also be invited to register for this study. The study involves no additional requirements from patients, as all questionnaires (baseline, 6-weeks, 6 months, and 12 months) are completed as part of their enrolment in the SHAReClinic.

Patients experience in the SHAReClinic involves the following: Upon registration, patients will be paired with a sexual health coach from their center and asked about their availability to receive a phone/video call from their sexual health coach. At the beginning of the first clinic visit, participants will be asked to complete a set of questionnaires. The questionnaires take around 10-15 minutes to complete. Patients are also asked to complete the same questionnaires at 6 week, 6 months and 12 months. The topics covered in each clinic visit vary and are based on the treatment schedules of the participants. A Q\&A session on the web page will be available for participants to leave any questions or concerns regarding their sexual health, rehabilitation process and the content of the portal. Participants are free to request for a check-in call with their sexual health coach if they want to chat about their concerns by phone. Each clinic visit will last approximately 30 minutes. If participants miss their clinic visit, they will get a notification from the platform and then a reminder call from their sexual health coach. At the end of their final SHAReClinic clinic visit, participants will be asked to fill out a satisfaction questionnaire, including questions about the ease of access to the website, their experience with SHAReClinic portals and communication with their sexual health coach. The satisfaction questionnaire takes about 10 minutes to complete.

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
Medical subject headings
Prostatic Neoplasms, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6 weeks, 6 months, and 12 months

  2. 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.

    Measured: Baseline, 6 weeks, 6 months, and 12 months

  3. 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.

    Measured: Baseline, 6 weeks, 6 months, and 12 months

  4. 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.

    Measured: Baseline, 6 weeks, 6 months, and 12 months

  5. 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.

    Measured: Final clinic visit (12 months)

Secondary outcomes (3)
  1. 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.

    Measured: From enrollment to the end of 1st year on SHAReClinic

  2. 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.

    Measured: From enrollment to the end of 1st year on SHAReClinic

  3. 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.

    Measured: From enrollment to the end of 1st year on SHAReClinic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start1 Jun 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
575 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877598
Sponsor's protocol ID
708251
Status last verified
Dec 2025
First submitted
6 Mar 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Sexual Dysfunction, Physiological, run by University Health Network, Toronto at 10 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Steven Guirguis, MA (416-946-4501 ext. 2598, steven.guirguis@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing SHAReClinic's Impact on Sexual Function and Satisfaction (time frame: Baseline, 6 weeks, 6 months, and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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