Prostate CancerNCT03396848
Sexual Health and Rehabilitation eClinic (SHAReClinic)
A study testing SHAReClinic in people with Prostate Cancer and Sexual Dysfunction, run by University Health Network, Toronto at 5 sites in Canada.
Trial summary
In addressing the need for effective post treatment support for men (and their partners) following treatment for prostate cancer, the investigators will employ an innovative SHAReClinic (Sexual health and Rehabilitation eClinic Program) that emphasizes: 1) a bio-medical component (erectile rehabilitation), focused on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunction
- What is being tested?
- SHAReClinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 5 sitesCanada
- Study dates
- 23 Aug 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting all of the following inclusion criteria will be eligible for the study:
- Men who are scheduled for a RP (open, robotic) for the first-line treatment for localized prostate cancer;
- Men who are scheduled for Radiation treatment (brachytherapy, external beam) for localized prostate cancer as their first line of treatment
- Men who are hormone and/or chemotherapy-naïve
- Men who have access a computer with internet access
- Men who are 18 years of age or older
- OR:
- Partners of men who meet the above criteria and are 18 years of age or older
Who cannot join
- Patients/couples will be excluded from study participation if:
- the patient or partner lacks English proficiency
- the patient is on nitrate therapy or has other contra-indications to phosphodiesterase type 5 inhibitors (PDE5i's)
- the patient or partner has a medical condition that would preclude safe sexual activity
- the patient has had previous treatment for PC
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V8
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 2M9
Vancouver Coastal Health
Vancouver, British Columbia
About this study
Official title: An Online Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners: a Feasibility Study
In addressing the need for effective post treatment support for men (and their partners) following treatment for prostate cancer, the investigators will employ an innovative SHAReClinic (Sexual health and Rehabilitation eClinic Program) that emphasizes: 1) a bio-medical component (erectile rehabilitation), focused on the long term return of erectile functioning firm enough for penetration with or without erectile agents/devices; and 2) a psychological component (intimacy maintenance), involving the maintenance or restoration of couples' intimacy. Through comparison research, the eClinic will be analyzed and made comparable in quality to the programs offered currently at leading institutions in major metropolitan areas, thus providing personalized, comprehensive cancer care to all Canadians.
Read the detailed description
The considerable prevalence of sexual dysfunction (SD) after prostate cancer treatment, coupled with the severity/breadth of impact and lack of successful intervention makes SD post-treatment one of the most substantial health-related quality of life burdens in all of cancer survivorship. In 2014, it is estimated that 24,000 Canadians will be diagnosed with prostate cancer (PC) and 4,100 men will die of the disease. Accordingly, 19,900 men will be added to the pool of Canadian prostate cancer survivors in just one year. Today, there are approximately 250,000 prostate cancer survivors across Canada. Research with men in post-radiation therapy indicates that 24-59% suffer SD, while 40%-75% of men in post-radical prostatectomy suffer SD. Sixty percent of men experience significant distress in response to SD. Distress is especially elevated in younger men and evidence suggests that partners may experience even greater distress than patients. Research examining the nature of the distress reveals that the significance of SD reaches far beyond the ability to have an erection, and resides in its complex psychosocial implications, including intimacy loss, low self-esteem, guilt, depression, anxiety, and anger. Additional evidence suggests that patients' SD-related distress can lead to long-term maladjustment in their overall relationships with their partners. The burden of SD following treatment for prostate cancer is responsible for the single greatest impact on patient/partner/couple health-related quality of life; substantially more so than concern for cancer recurrence. Unfortunately, there are no reported interventions to date that have been successful in reducing the impact of SD following treatment, on long-term couple health-related quality of life. Accordingly, given the extensive impact of SD on patient/partner health-related quality of life (HRQOL) there is an existent need for restorative/rehabilitative intervention.
The current study proposes the application of an online bio-psychosocial intervention to address sexual dysfunction following treatment for prostate cancer. The bio-medical approach will apply a broader definition of penile rehabilitation which will focus on applying a systematic pro-erectile aid regimen to assist patients in achieving long-term return of erectile functioning, firm enough for penetration, with or without the use of pro-erectile agents/devices. The investigators have termed this bio-medical rehabilitation approach, Erectile Rehabilitation. As such, the rehabilitation algorithm includes but is not limited to the goal of return of natural functioning. Overall, the investigators endeavour to help patients find and adapt to the least invasive pro-erectile agent /device that is successful in achieving desired erections. The investigators justify this approach through extensive research that demonstrates that, following prostate cancer treatment, patients who use pro-erectile agents report better erectile functioning versus those who do not use pro-erectile agents. In addition to addressing Erectile Rehabilitation, this intervention will offer psychosocial support, with the goal of helping couples maintain or restore intimacy after treatment for prostate cancer. Health coach interventions aim at improving sexual satisfaction following prostate cancer treatment have been shown to improve distress and sexual function, and provide patients with the information on pro-erectile aids and couples' experiences.
- Conditions
- Prostate Cancer, Sexual Dysfunction
- Being tested
- SHAReClinic
- Keywords
- Rehabilitation, Online Clinic
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAReClinicOther
Online clinic with educational modules
| Study group | Role | What they receive |
|---|---|---|
| SHAReClinic | Experimental | All participants will have access to the online clinic Receives: Other: SHAReClinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of relationship and Intimacy from different time points
Miller Social Intimacy Scale (MSIS):MSIS is a 17-item measure of the maximum level of intimacy currently experienced is used in this study. Each question has a scale of 1-10 with a higher score representing higher level of intimacy.
Measured: This questionnaire will be completed by coupled participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of Relationship and Intimacy for male participants from different time points
The Sexual Health Inventory for Men (SHIM): SHIM was developed and validated as a brief, easily administered, patient-reported diagnostic tool for men as a measure for male optimal sexual health for Bio-medical Responders and Bio-medical Non-Responders. SHIM has 5 items in all with a scale from 0(1) to 5. Higher number indicates a better sexual function.
Measured: This questionnaire will be completed by male participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of Relationship and Intimacy for female participants from different time points
Female Sexual Function Inventory (FSFI): the FSFI is a brief, 19-item self-report measure of female sexual function that provides scores on six domains of sexual function (Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain) as well as a total score. The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Higher score indicates a better sexual function.
Measured: This questionnaire will be completed by female participants at T1 (pre-treatment online visit), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment)
Change of sexual function from different time points
Prolonged Grief about the Loss of Sexual Function (PGLSF) is adapted from Prigerson's measure of prolonged grief in bereavement. Combinatoric analyses identified the most sensitive and specific Prolonged Grief Disorder (PGD) algorithm that was then tested to evaluate its psychometric validity. Criteria require reactions to a significant loss that involve the experience of yearning (e.g., physical or emotional suffering as a result of the desired, but unfulfilled, reunion with the deceased) and at least five of the following nine symptoms experienced at least daily or to a disabling degree: feeling emotionally numb, stunned, or that life is meaningless; experiencing mistrust; bitterness over the loss; difficulty accepting the loss; identity confusion; avoidance of the reality of the loss; or difficulty moving on with life. The PGLSf consists of 22 items with a Likert scale of 1 to 5: higher score indicates a higher grief level.
Measured: This questionnaire will be completed by all participants at T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of Sexual desire and activity from different time points
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sexual Interest and sexual activity are used were to measure sexual activity and sexual desire in this study. For patients with cancer who may or may not have sexual dysfunction, the PROMIS SexFS measures provide a comprehensive assessment of key domains of sexual function and satisfaction. The questionnaire has 13 items in total with Likert scale of 1 to 5. Higher score indicates a higher sexual activity/desire level.
Measured: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of psychological stress from different time points
Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression that participants are experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each question has a scale of 0 to 3 and the total score can be calculated for the two domains (anxiety and depression) by adding the scores together. For each domain, a score of 0-7 = Normal level of anxiety/depression; a score of 8-10 = borderline case of anxiety/depression; 11-21 = case of anxiety/depression.
Measured: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of Sexual Distress from different time points
Sexual Distress Scale (SDS) is used in this study to measure sexual distress. SDS was created and validated to assess sexually related distress-that is, distress associated with inadequate or impaired sexual function. It has 13 items in all with a Likert scale from 0 to 4; higher score indicates a higher distress level.
Measured: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of prostate cancer- related Quality of Life from different time points
Patient Oriented Prostate Cancer Utility Survey (PORPUS) was used in this study to measure quality of life for patients after prostate treatment. The PORPUS contains 10 questions. There are 5 general questions (pain, energy, emotional well-being, social well-being, and relationship with physician) and 5 prostate cancer-specific questions (sexual function and desire, urinary frequency and incontinence, and bowel function), each with four to six possible answers, scoring 1 to 4 (6). Higher score indicates a better function in the respective domain.
Measured: This questionnaire will be completed by patient-participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Change of prostate cancer- related Quality of Life from different time points (expanded)
Expanded Prostate Cancer Index Composite (EPIC) is used in this study: EPIC is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. The version we used contains 26 item and the 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-itemscale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL (Health-Related Quality of Life).
Measured: This questionnaire will be completed by patient-participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online clinic visits.
Change of general Quality of Life from different time points
EQ-5D Health Questionnaire is used in this study as a standardized instrument to measure of health-related quality of life. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels of severity with a higher number indicating better quality of life.
Measured: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Secondary outcomes (2)
Demographic Information
Demographic Questionnaire will be used to collect social-demographic information from participants for analysis.
Measured: This questionnaire will be completed by all participants at T1 (pre-treatment) online visit
Satisfaction to the program
Satisfaction Questionnaire was used to receive participants' feedback on the website and their experience with the online clinic visits. The questionnaire contains 29 items in 4 domains: Satisfaction with SHAReClinic Program Referral, Registration \& Onboarding; Satisfaction with Online SHAReClinic Portal and Content (Educational Modules); Satisfaction with SHAReClinic Health Coach and Overall Satisfaction with SHAReClinic Program. A Likert Scale of 1 to 5 is used for the items with a higher score indicating better satisfaction.
Measured: This questionnaire will be completed by all participants at T6 online visit (12 months after treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start23 Aug 2017
- Primary completion30 Apr 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient will have access to an online clinic after their prostate cancer treatment. This is a feasibility study to determine whether it would be feasible to implement SHAReClinic as a pan-Canadian sexual health and rehabilitation intervention
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre, Vancouver Coastal Health, Sunnybrook Health Sciences Centre, Nova Scotia Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Andrew G Matthew, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396848
- Sponsor's protocol ID
- SHAReClinic 001
- Status last verified
- Apr 2021
- First submitted
- 12 Dec 2017
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study data will be shared via an academic publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03396848
- Acronym / sponsor ID
- SHAReClinic 001
- Conditions
- Prostate Cancer, Sexual Dysfunction
- Keywords
- Rehabilitation, Online Clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre, Vancouver Coastal Health, Sunnybrook Health Sciences Centre, Nova Scotia Cancer Centre
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In addressing the need for effective post treatment support for men (and their partners) following treatment for prostate cancer, the investigators will employ an innovative SHAReClinic (Sexual health and Rehabilitation eClinic Program) that emphasizes: 1) a bio-medical component (erectile rehabilitation), focused on the long term return of erectile functioning firm enough for penetration with or without erectile agents/devices; and 2) a psychological component (intimacy maintenance), involving the maintenance or restoration of couples' intimacy. Through comparison research, the eClinic will be analyzed and made comparable in quality to the programs offered currently at leading institutions in major metropolitan areas, thus providing personalized, comprehensive cancer care to all Canadians.
Detailed description
The considerable prevalence of sexual dysfunction (SD) after prostate cancer treatment, coupled with the severity/breadth of impact and lack of successful intervention makes SD post-treatment one of the most substantial health-related quality of life burdens in all of cancer survivorship. In 2014, it is estimated that 24,000 Canadians will be diagnosed with prostate cancer (PC) and 4,100 men will die of the disease. Accordingly, 19,900 men will be added to the pool of Canadian prostate cancer survivors in just one year. Today, there are approximately 250,000 prostate cancer survivors across Canada. Research with men in post-radiation therapy indicates that 24-59% suffer SD, while 40%-75% of men in post-radical prostatectomy suffer SD. Sixty percent of men experience significant distress in response to SD. Distress is especially elevated in younger men and evidence suggests that partners may experience even greater distress than patients. Research examining the nature of the distress reveals that the significance of SD reaches far beyond the ability to have an erection, and resides in its complex psychosocial implications, including intimacy loss, low self-esteem, guilt, depression, anxiety, and anger. Additional evidence suggests that patients' SD-related distress can lead to long-term maladjustment in their overall relationships with their partners. The burden of SD following treatment for prostate cancer is responsible for the single greatest impact on patient/partner/couple health-related quality of life; substantially more so than concern for cancer recurrence. Unfortunately, there are no reported interventions to date that have been successful in reducing the impact of SD following treatment, on long-term couple health-related quality of life. Accordingly, given the extensive impact of SD on patient/partner health-related quality of life (HRQOL) there is an existent need for restorative/rehabilitative intervention.
The current study proposes the application of an online bio-psychosocial intervention to address sexual dysfunction following treatment for prostate cancer. The bio-medical approach will apply a broader definition of penile rehabilitation which will focus on applying a systematic pro-erectile aid regimen to assist patients in achieving long-term return of erectile functioning, firm enough for penetration, with or without the use of pro-erectile agents/devices. The investigators have termed this bio-medical rehabilitation approach, Erectile Rehabilitation. As such, the rehabilitation algorithm includes but is not limited to the goal of return of natural functioning. Overall, the investigators endeavour to help patients find and adapt to the least invasive pro-erectile agent /device that is successful in achieving desired erections. The investigators justify this approach through extensive research that demonstrates that, following prostate cancer treatment, patients who use pro-erectile agents report better erectile functioning versus those who do not use pro-erectile agents. In addition to addressing Erectile Rehabilitation, this intervention will offer psychosocial support, with the goal of helping couples maintain or restore intimacy after treatment for prostate cancer. Health coach interventions aim at improving sexual satisfaction following prostate cancer treatment have been shown to improve distress and sexual function, and provide patients with the information on pro-erectile aids and couples' experiences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient will have access to an online clinic after their prostate cancer treatment. This is a feasibility study to determine whether it would be feasible to implement SHAReClinic as a pan-Canadian sexual health and rehabilitation intervention
| Arm | Type | Receives |
|---|---|---|
| SHAReClinic | Experimental | Other: SHAReClinicAll participants will have access to the online clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men who are scheduled for a RP (open, robotic) for the first-line treatment for localized prostate cancer;
- Men who are scheduled for Radiation treatment (brachytherapy, external beam) for localized prostate cancer as their first line of treatment
- Men who are hormone and/or chemotherapy-naïve
- Men who have access a computer with internet access
- Men who are 18 years of age or older
Key exclusion criteria (5 listed)
- the patient or partner lacks English proficiency
- the patient is on nitrate therapy or has other contra-indications to phosphodiesterase type 5 inhibitors (PDE5i's)
- the patient or partner has a medical condition that would preclude safe sexual activity
- the patient has had previous treatment for PC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAReClinicOnline clinic with educational modules | Other | SHAReClinic |
Primary outcome
Change of relationship and Intimacy from different time points
Time frame: This questionnaire will be completed by coupled participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Miller Social Intimacy Scale (MSIS):MSIS is a 17-item measure of the maximum level of intimacy currently experienced is used in this study. Each question has a scale of 1-10 with a higher score representing higher level of intimacy.
Change of Relationship and Intimacy for male participants from different time points
Time frame: This questionnaire will be completed by male participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
The Sexual Health Inventory for Men (SHIM): SHIM was developed and validated as a brief, easily administered, patient-reported diagnostic tool for men as a measure for male optimal sexual health for Bio-medical Responders and Bio-medical Non-Responders. SHIM has 5 items in all with a scale from 0(1) to 5. Higher number indicates a better sexual function.
Change of Relationship and Intimacy for female participants from different time points
Time frame: This questionnaire will be completed by female participants at T1 (pre-treatment online visit), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment)
Female Sexual Function Inventory (FSFI): the FSFI is a brief, 19-item self-report measure of female sexual function that provides scores on six domains of sexual function (Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain) as well as a total score. The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Higher score indicates a better sexual function.
Change of sexual function from different time points
Time frame: This questionnaire will be completed by all participants at T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Prolonged Grief about the Loss of Sexual Function (PGLSF) is adapted from Prigerson's measure of prolonged grief in bereavement. Combinatoric analyses identified the most sensitive and specific Prolonged Grief Disorder (PGD) algorithm that was then tested to evaluate its psychometric validity. Criteria require reactions to a significant loss that involve the experience of yearning (e.g., physical or emotional suffering as a result of the desired, but unfulfilled, reunion with the deceased) and at least five of the following nine symptoms experienced at least daily or to a disabling degree: feeling emotionally numb, stunned, or that life is meaningless; experiencing mistrust; bitterness over the loss; difficulty accepting the loss; identity confusion; avoidance of the reality of the loss; or difficulty moving on with life. The PGLSf consists of 22 items with a Likert scale of 1 to 5: higher score indicates a higher grief level.
Change of Sexual desire and activity from different time points
Time frame: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sexual Interest and sexual activity are used were to measure sexual activity and sexual desire in this study. For patients with cancer who may or may not have sexual dysfunction, the PROMIS SexFS measures provide a comprehensive assessment of key domains of sexual function and satisfaction. The questionnaire has 13 items in total with Likert scale of 1 to 5. Higher score indicates a higher sexual activity/desire level.
Change of psychological stress from different time points
Time frame: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression that participants are experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each question has a scale of 0 to 3 and the total score can be calculated for the two domains (anxiety and depression) by adding the scores together. For each domain, a score of 0-7 = Normal level of anxiety/depression; a score of 8-10 = borderline case of anxiety/depression; 11-21 = case of anxiety/depression.
Change of Sexual Distress from different time points
Time frame: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Sexual Distress Scale (SDS) is used in this study to measure sexual distress. SDS was created and validated to assess sexually related distress-that is, distress associated with inadequate or impaired sexual function. It has 13 items in all with a Likert scale from 0 to 4; higher score indicates a higher distress level.
Change of prostate cancer- related Quality of Life from different time points
Time frame: This questionnaire will be completed by patient-participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
Patient Oriented Prostate Cancer Utility Survey (PORPUS) was used in this study to measure quality of life for patients after prostate treatment. The PORPUS contains 10 questions. There are 5 general questions (pain, energy, emotional well-being, social well-being, and relationship with physician) and 5 prostate cancer-specific questions (sexual function and desire, urinary frequency and incontinence, and bowel function), each with four to six possible answers, scoring 1 to 4 (6). Higher score indicates a better function in the respective domain.
Change of prostate cancer- related Quality of Life from different time points (expanded)
Time frame: This questionnaire will be completed by patient-participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online clinic visits.
Expanded Prostate Cancer Index Composite (EPIC) is used in this study: EPIC is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. The version we used contains 26 item and the 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-itemscale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL (Health-Related Quality of Life).
Change of general Quality of Life from different time points
Time frame: This questionnaire will be completed by all participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.
EQ-5D Health Questionnaire is used in this study as a standardized instrument to measure of health-related quality of life. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels of severity with a higher number indicating better quality of life.
2 secondary outcomes
Demographic Information
Time frame: This questionnaire will be completed by all participants at T1 (pre-treatment) online visit
Satisfaction to the program
Time frame: This questionnaire will be completed by all participants at T6 online visit (12 months after treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Undecided. The study data will be shared via an academic publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew G Matthew, PhD principal investigator
University Health Network, Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHAReClinic in people with Prostate Cancer and Sexual Dysfunction, run by University Health Network, Toronto at 5 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 8 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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of relationship and Intimacy from different time points (time frame: This questionnaire will be completed by coupled participants at T1 (pre-treatment), T2 (6 weeks after treatment), T5 (6 months after treatment) and T6 (12 months after treatment) online visits.). The study lists 10 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 14 Apr 2021.