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Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Andrew Matthew, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00335634
First received: June 8, 2006
Last updated: November 22, 2013
Last verified: November 2013

June 8, 2006
November 22, 2013
June 2006
July 2009   (final data collection date for primary outcome measure)
  • Semi-Structured Interview - Patient [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Patient [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Patient [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Partner [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Partner [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Partner [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Couple [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Couple [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
  • Semi-Structured Interview - Couple [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00335634 on ClinicalTrials.gov Archive Site
  • The International Index of Erectile Function [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners
  • Index of Sexual Life [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess sexual desire and overall sexual satisfaction in female partners
  • Dyadic Adjustment Scale [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure couple distress
  • Hospital Anxiety and Depression Scale [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure anxiety and depression
  • The International Index of Erectile Function [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners
  • The International Index of Erectile Function [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners
  • Index of Sexual Life [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess sexual desire and overall sexual satisfaction in female partners
  • Index of Sexual Life [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess sexual desire and overall sexual satisfaction in female partners
  • Dyadic Adjustment Scale [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure couple distress
  • Dyadic Adjustment Scale [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure couple distress
  • Hospital Anxiety and Depression Scale [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure anxiety and depression
  • Hospital Anxiety and Depression Scale [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure anxiety and depression
  • Brief Profile of Mood States [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure emotional distress
  • Brief Profile of Mood States [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure emotional distress
  • Brief Profile of Mood States [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure emotional distress
  • Miller Social Intimacy Scale [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure patient-partner intimacy
  • Miller Social Intimacy Scale [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure patient-partner intimacy
  • Miller Social Intimacy Scale [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to measure patient-partner intimacy
  • Sternberg Triangular Love Scale [ Time Frame: 3-6 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion
  • Sternberg Triangular Love Scale [ Time Frame: 12-15 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion
  • Sternberg Triangular Love Scale [ Time Frame: 21-24 months post-radical prostatectomy ] [ Designated as safety issue: No ]
    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion
Not Provided
Not Provided
Not Provided
 
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Prostate Cancer
  • Erectile Dysfunction Following Radical Prostatectomy
  • Sexual Dysfunction
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00335634
PC-05-0813
Not Provided
Andrew Matthew, University Health Network, Toronto
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Andrew G Matthew, PhD, C.Psych University Health Network, Toronto
University Health Network, Toronto
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP