Clinical Trial on Sexual Dysfunction, Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

We are studying the impact of sexual dysfunction following radical prostatectomy on patient and partners' experiences of intimacy. Research with men in post-radical prostatectomy recovery indicates 25%-75% experience sexual dysfunction. Many patients experience anxiety and distress related to sexual difficulties. These experiences may progress and result in long-term problems in the relationship between patients and their partners. Despite apparent levels of effectiveness, up to half of the patients who turn to sexually assistive aids after surgical removal of the prostate discontinue use of the aids within one year. Additionally, difficulties in communicating about sexual impairments can significantly interfere with the couples' ability to achieve successful adaptation. We are interested in studying patient and partner experiences with sexual dysfunction in order to understand its effects on sexual and non-sexual intimacy.

Participation in this study will involve completing 6 confidential face-to-face interviews on three separate occasions (3-6 months, 12-15 months, and 21-24 months post-surgery). On each occasion, participants will be required to take part in a "couple's" interview with his/her partner, as well as an individual interview. The interviews will provide participants with the opportunity to discuss the impact of sexual dysfunction on mood, thoughts, and communication with their partners. Demographic information will be collected at the initial interview. As well, at each of the 3 time points, participants will also be asked to complete a questionnaire package containing 6 psychological questionnaires. All questionnaires and interview material will be kept strictly confidential.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Etobicoke, Ontario, Canada, M9V 1R8
    - Etobicoke General Hospital
  - Toronto, Ontario, Canada, M5G 2M9
    - The Prostate Centre, Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.

Description

Inclusion Criteria:

Radical prostatectomy treatment for prostate cancer at Princess Margaret Hospital or Etobicoke General Hospital
At least 3 months, but less than 6 months post-radical prostatectomy
Experience sexual dysfunction as a result of radical prostatectomy
Must have an intimate partner and be able to participate as a couple

Exclusion Criteria:

Detectable prostate specific antigen (PSA) post-radical prostatectomy
Patient or partner unable to speak English
Patient or partner unwilling to allow interviews to be recorded
Patient or partner unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Semi-Structured Interview - Patient Time Frame: 3-6 months post-radical prostatectomy	3-6 months post-radical prostatectomy
Semi-Structured Interview - Patient Time Frame: 12-15 months post-radical prostatectomy	12-15 months post-radical prostatectomy
Semi-Structured Interview - Patient Time Frame: 21-24 months post-radical prostatectomy	21-24 months post-radical prostatectomy
Semi-Structured Interview - Partner Time Frame: 3-6 months post-radical prostatectomy	3-6 months post-radical prostatectomy
Semi-Structured Interview - Partner Time Frame: 12-15 months post-radical prostatectomy	12-15 months post-radical prostatectomy
Semi-Structured Interview - Partner Time Frame: 21-24 months post-radical prostatectomy	21-24 months post-radical prostatectomy
Semi-Structured Interview - Couple Time Frame: 3-6 months post-radical prostatectomy	3-6 months post-radical prostatectomy
Semi-Structured Interview - Couple Time Frame: 12-15 months post-radical prostatectomy	12-15 months post-radical prostatectomy
Semi-Structured Interview - Couple Time Frame: 21-24 months post-radical prostatectomy	21-24 months post-radical prostatectomy

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator: Andrew G Matthew, PhD, C.Psych, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria