Clinical trial NCT03396848: Sexual Health and Rehabilitation eClinic (SHAReClinic)
Official title: An Online Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients and Their Partners: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Sexual Dysfunction
Keywords: Rehabilitation
Online Clinic
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Tom Baker Cancer Centre
name: Vancouver Coastal Health
name: Sunnybrook Health Sciences Centre
name: Nova Scotia Cancer Centre
First posted: 2018-01-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change of relationship and Intimacy from different time points
timeFrame: 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.
measure: Change of Relationship and Intimacy for male participants from different time points
timeFrame: 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.
measure: Change of Relationship and Intimacy for female participants from different time points
timeFrame: 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)
measure: Change of sexual function from different time points
timeFrame: 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.
measure: Change of Sexual desire and activity from different time points
timeFrame: 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.
measure: Change of psychological stress from different time points
timeFrame: 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.
measure: Change of Sexual Distress from different time points
timeFrame: 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.
measure: Change of prostate cancer- related Quality of Life from different time points
timeFrame: 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.
measure: Change of prostate cancer- related Quality of Life from different time points (expanded)
timeFrame: 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.
measure: Change of general Quality of Life from different time points
timeFrame: 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:
measure: Demographic Information
timeFrame: This questionnaire will be completed by all participants at T1 (pre-treatment) online visit
measure: Satisfaction to the program
timeFrame: This questionnaire will be completed by all participants at T6 online visit (12 months after treatment).
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Andrew G Matthew, PhD
role: PRINCIPAL_INVESTIGATOR
References: