Sexual Health and Rehabilitation eClinic (SHAReClinic)

NCT ID: NCT03396848

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2021-12-31

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.

Conditions

Prostate Cancer; Sexual Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SHAReClinic

All participants will have access to the online clinic

Group Type: EXPERIMENTAL

SHAReClinic

Intervention Type: OTHER

Online clinic with educational modules

Interventions

SHAReClinic

Online clinic with educational modules

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tom Baker Cancer Centre

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Nova Scotia Cancer Centre

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew G Matthew, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

SHAReClinic 001

Identifier Type: -

Identifier Source: org_study_id