NCT02640131

A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Erectile Dysfunction
• Sexual Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Biomedical Component	Bio-medical: The bio-medical component includes an appointment with urologist pre-operatively and 5 follow-up appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices.
BEHAVIORAL	Psychosocial Component	Psychosocial: aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive standardized sexual health counselor (SexHC) counseling and manualized support.
BEHAVIORAL	Attention Control	Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) at 3-4, 7-8, and 12-13 months post radical prostatectomy (RP). Couples will receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: Nutrition, Exercise, and You (CPC) manual (a patient self-help manual written by the Princess Margaret Prostate Centre team). The core topics discussed during the counselling sessions include: preparation for immediate post-RP recovery, Kegel exercises, nutrition and prostate cancer (PC), exercise and PC, and maintaining healthy lifestyle change.

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-01-01
• Completion: 2017-05-01
• First posted: 2015-12-28
• Last updated: 2018-06-06

Locations

1 site across 1 country: Canada