Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by University Health Network, Toronto.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Canadian Institutes of Health Research (CIHR)

Information provided by:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00335634

First received: June 8, 2006

Last updated: April 21, 2011

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2006

Last Updated Date

April 21, 2011

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00335634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Prostate Cancer
Radical Prostatectomy
Sexual Dysfunction

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00335634

Other Study ID Numbers ^ICMJE

PC-05-0813

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Andrew Matthew, University Health Network

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)

Investigators ^ICMJE

Principal Investigator:

Andrew G Matthew, PhD, C.Psych

University Health Network, Toronto

Information Provided By

University Health Network, Toronto

Verification Date

June 2008

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

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