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Sponsors and Collaborators: |
University Health Network, Toronto Canadian Institutes of Health Research (CIHR) |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00335634 |
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 |
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Prostate Cancer Prostatectomy Sexual Dysfunction |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment |
Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Prostate Centre, Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Etobicoke General Hospital | |
Etobicoke, Ontario, Canada, M9V 1R8 |
Principal Investigator: | Andrew G Matthew, PhD, C.Psych | University Health Network, Toronto |
Responsible Party: | University Health Network ( Dr. Andrew Matthew ) |
Study ID Numbers: | PC-05-0813 |
Study First Received: | June 8, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00335634 |
Health Authority: | Canada: Ethics Review Committee |
Prostate Cancer Radical Prostatectomy Sexual Dysfunction |
Intimacy Adaptation Psychosocial Oncology |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |