Clinical trial NCT02640131: A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study
Official title: A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction
Sexual Dysfunction
Keywords: prostate cancer
radical prostatectomy
survivorship
quality of life
erectile dysfunction
sexual dysfunction
feasibility study
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.

Detailed description: Previous Research: The prevalence of sexual dysfunction (SD) after prostate cancer surgery, coupled with the severity of impact and lack of successful intervention, make SD one of the most substantial health-related quality of life burdens in all of cancer survivorship. In 2012, 21,000 men will be added to the pool of Canadian prostate cancer (PC) survivors. Approximately 70% of men will suffer SD post-surgery and 60% will experience significant distress in response to SD. Similarly, partners may experience even greater distress than patients. Research examining the nature of the distress reveals that the significance of SD extends beyond the ability to have an erection, and includes guilt, depression, anxiety, anger, and reductions in intimacy. Unfortunately, there are no reported interventions that have been successful in reducing the impact of SD on long term couple health-related quality of life.

Project Description: Men and their partners need an effective intervention to help them adapt to sexual dysfunction following prostate cancer surgery. In addressing this need we propose an innovative biomedical-psychosocial Intervention that emphasizes: 1) multidisciplinary intervention teams; 2) the active participation of the partner; and 3) a broad-spectrum medical, psychological, and social approach. The treatment goal of the intervention is to promote intimacy and optimal sexual health in affected couples. This is a preliminary study designed to determine the feasibility of running a large scale randomized controlled trial comparing the new biomedical-psychosocial intervention to an attention control condition.

Impact and Relevance: The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.

Eligibility criteria: Inclusion Criteria:

* scheduled for a Radical Prostatectomy at the Princess Margaret Cancer Centre(open, laparoscopic, robotic) for the first-line treatment of prostate cancer regardless of clinical stage of disease
* are hormone and/or chemotherapy-naïve
* have a sexual partner (heterosexual or homosexual) for at least the past 6 months
* are 18 years of age or older
* Partners of men who meet the above criteria and are 18 years of age or older

Exclusion Criteria:

* 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 does not have a sexual partner
* the patient or partner has a medical condition that would preclude safe sexual activity
* the patient has had previous treatment for PC
* the patient has previously and regularly used sexual aids/devices during the course of sexual activity

Primary outcomes:
measure: Miller Social Intimacy Scale (MSIS)
timeFrame: At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy
Secondary outcomes:
measure: International Index of Erectile Function (IIEF)
timeFrame: At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy
measure: Female Sexual Function Inventory (FSFI)
timeFrame: At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
timeFrame: 13-14 months post-radical prostatectomy
measure: Sexual Health Rehabilitation Record
timeFrame: 3-4 months post-radical prostatectomy;7-8 months post-radical prostatectomy;12-13 months post-radical prostatectomy
measure: Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Prostate Centre, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Andrew G Matthew, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References: