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Clinical Trials/NCT00335634
NCT00335634
Completed
Not Applicable

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment

University Health Network, Toronto2 sites in 1 country50 target enrollmentJune 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University Health Network, Toronto
Enrollment
50
Locations
2
Primary Endpoint
Semi-Structured Interview - Patient
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to explore patient and partner experiences with sexual dysfunction following radical prostatectomy, in order to understand its effects on sexual and non-sexual intimacy. This will enable us to provide assistance in the future to individuals experiencing similar circumstances.

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.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
July 2009
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Semi-Structured Interview - Patient

Time Frame: 21-24 months post-radical prostatectomy

Semi-Structured Interview - Couple

Time Frame: 21-24 months post-radical prostatectomy

Semi-Structured Interview - Partner

Time Frame: 21-24 months post-radical prostatectomy

Secondary Outcomes

  • The International Index of Erectile Function(21-24 months post-radical prostatectomy)
  • Dyadic Adjustment Scale(21-24 months post-radical prostatectomy)
  • Miller Social Intimacy Scale(21-24 months post-radical prostatectomy)
  • Brief Profile of Mood States(21-24 months post-radical prostatectomy)
  • Index of Sexual Life(21-24 months post-radical prostatectomy)
  • Hospital Anxiety and Depression Scale(21-24 months post-radical prostatectomy)
  • Sternberg Triangular Love Scale(21-24 months post-radical prostatectomy)

Study Sites (2)

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