Clinical trial NCT06877598: Canada-wide Implementation of a Virtual Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners
Official title: Canada-wide Implementation of a Virtual Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Sexual Dysfunction, Physiological
Sexual Dysfunction, Psychological
Sexual Dysfunction
Virtual Care
Virtual Clinic
Survivorship
Implementation of Evidence Based Programs
Implementation
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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 575
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing SHAReClinic's Impact on Sexual Function and Satisfaction
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Assessing SHAReClinic's Impact on Sexual Distress
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Assessing SHAReClinic's Impact on Relational Intimacy
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Assessing SHAReClinic's Impact on Health-Related Quality of Life
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Overall Patient Satisfaction with SHAReClinic
timeFrame: Final clinic visit (12 months)
Secondary outcomes:
measure: System-Level Evaluation: Enrolment, Attrition, and Adherence Rates
timeFrame: From enrollment to the end of 1st year on SHAReClinic
measure: Evaluating Patient Interest and Acceptance of SHAReClinic
timeFrame: From enrollment to the end of 1st year on SHAReClinic
measure: Data Completeness and Quality
timeFrame: From enrollment to the end of 1st year on SHAReClinic
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Authority
state: British Columbia
city: Winnipeg
country: Canada
facility: Men's Health Clinic Manitoba
state: Manitoba
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Edmonton
country: Canada
facility: Dianne & Irving Kipnes Urology Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
city: Ottawa
country: Canada
facility: Grass Family Men's Health Center
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Saskatoon
country: Canada
facility: St. Paul's Hospital
state: Saskatchewan
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Andrew Matthew, PhD. C.Psych
role: PRINCIPAL_INVESTIGATOR
References: