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Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335634
First Posted: June 12, 2006
Last Update Posted: December 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose
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.

Condition
Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy Sexual Dysfunction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Semi-Structured Interview - Patient [ Time Frame: 3-6 months post-radical prostatectomy ]
  • Semi-Structured Interview - Patient [ Time Frame: 12-15 months post-radical prostatectomy ]
  • Semi-Structured Interview - Patient [ Time Frame: 21-24 months post-radical prostatectomy ]
  • Semi-Structured Interview - Partner [ Time Frame: 3-6 months post-radical prostatectomy ]
  • Semi-Structured Interview - Partner [ Time Frame: 12-15 months post-radical prostatectomy ]
  • Semi-Structured Interview - Partner [ Time Frame: 21-24 months post-radical prostatectomy ]
  • Semi-Structured Interview - Couple [ Time Frame: 3-6 months post-radical prostatectomy ]
  • Semi-Structured Interview - Couple [ Time Frame: 12-15 months post-radical prostatectomy ]
  • Semi-Structured Interview - Couple [ Time Frame: 21-24 months post-radical prostatectomy ]

Secondary Outcome Measures:
  • The International Index of Erectile Function [ Time Frame: 3-6 months post-radical prostatectomy ]
    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 ]
    Used to assess sexual desire and overall sexual satisfaction in female partners

  • Dyadic Adjustment Scale [ Time Frame: 3-6 months post-radical prostatectomy ]
    Used to measure couple distress

  • Hospital Anxiety and Depression Scale [ Time Frame: 3-6 months post-radical prostatectomy ]
    Used to measure anxiety and depression

  • The International Index of Erectile Function [ Time Frame: 12-15 months post-radical prostatectomy ]
    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 ]
    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 ]
    Used to assess sexual desire and overall sexual satisfaction in female partners

  • Index of Sexual Life [ Time Frame: 21-24 months post-radical prostatectomy ]
    Used to assess sexual desire and overall sexual satisfaction in female partners

  • Dyadic Adjustment Scale [ Time Frame: 12-15 months post-radical prostatectomy ]
    Used to measure couple distress

  • Dyadic Adjustment Scale [ Time Frame: 21-24 months post-radical prostatectomy ]
    Used to measure couple distress

  • Hospital Anxiety and Depression Scale [ Time Frame: 12-15 months post-radical prostatectomy ]
    Used to measure anxiety and depression

  • Hospital Anxiety and Depression Scale [ Time Frame: 21-24 months post-radical prostatectomy ]
    Used to measure anxiety and depression

  • Brief Profile of Mood States [ Time Frame: 3-6 months post-radical prostatectomy ]
    Used to measure emotional distress

  • Brief Profile of Mood States [ Time Frame: 12-15 months post-radical prostatectomy ]
    Used to measure emotional distress

  • Brief Profile of Mood States [ Time Frame: 21-24 months post-radical prostatectomy ]
    Used to measure emotional distress

  • Miller Social Intimacy Scale [ Time Frame: 3-6 months post-radical prostatectomy ]
    Used to measure patient-partner intimacy

  • Miller Social Intimacy Scale [ Time Frame: 12-15 months post-radical prostatectomy ]
    Used to measure patient-partner intimacy

  • Miller Social Intimacy Scale [ Time Frame: 21-24 months post-radical prostatectomy ]
    Used to measure patient-partner intimacy

  • Sternberg Triangular Love Scale [ Time Frame: 3-6 months post-radical prostatectomy ]
    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 ]
    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 ]
    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion


Enrollment: 50
Study Start Date: June 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335634


Locations
Canada, Ontario
Etobicoke General Hospital
Etobicoke, Ontario, Canada, M9V 1R8
The Prostate Centre, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Andrew G Matthew, PhD, C.Psych University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00335634     History of Changes
Other Study ID Numbers: PC-05-0813
First Submitted: June 8, 2006
First Posted: June 12, 2006
Last Update Posted: December 10, 2015
Last Verified: December 2015

Keywords provided by University Health Network, Toronto:
Prostate Cancer
Radical Prostatectomy
Sexual Dysfunction
Intimacy
Adaptation
Psychosocial Oncology

Additional relevant MeSH terms:
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders