Sexual Health and Rehabilitation eClinic (SHAReClinic)

NCT03396848 | Unknown

• 1 other identifier: SHAReClinic 001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer; Sexual Dysfunction

Keywords

Rehabilitation; Online Clinic

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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

  This questionnaire will be completed by all participants at T1 (pre-treatment) online visit

• Satisfaction to the program

  This questionnaire will be completed by all participants at T6 online visit (12 months after treatment).

Study Arms (1)

SHAReClinic

EXPERIMENTAL

All participants will have access to the online clinic

Other: SHAReClinic

Interventions

SHAReClinic OTHER

Online clinic with educational modules

SHAReClinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Tom Baker Cancer Centre: collaborator
• Vancouver Coastal Health: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Nova Scotia Cancer Centre: collaborator

Study Sites (5)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V8, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrew G Matthew, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: January 11, 2018
• Study Start: August 23, 2017
• Primary Completion: April 30, 2019
• Study Completion: December 31, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

CA (5)