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Trial NCT00335634

Resource URI: http://static.linkedct.org/resource/trials/NCT00335634
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linkedct:brief_title Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/10834>
linkedct:condition <http://static.linkedct.org/resource/condition/10849>
linkedct:condition <http://static.linkedct.org/resource/condition/12032>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 70 Years
linkedct:eligibility_minimum_age 35 Years
linkedct:eligibility_sampling_method Non-Probability Sample
linkedct:eligibility_study_pop Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.
linkedct:end_date June 2009
linkedct:enrollment 50 (xsd:int)
linkedct:firstreceived_date June 8, 2006
linkedct:id NCT00335634
rdfs:label Trial NCT00335634
linkedct:lastchanged_date June 3, 2008
linkedct:lead_sponsor_agency University Health Network, Toronto
linkedct:location <http://static.linkedct.org/resource/location/20508>
linkedct:location <http://static.linkedct.org/resource/location/20807>
linkedct:nct_id NCT00335634
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 1 (xsd:int)
linkedct:official_title Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment
linkedct:org_study_id PC-05-0813
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/2708>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/410>
foaf:page <http://clinicaltrials.gov/show/NCT00335634>
linkedct:phase N/A
linkedct:primary_completion_date December 2009
linkedct:source University Health Network, Toronto
linkedct:start_date June 2006
linkedct:study_design Case-Only, Prospective
linkedct:study_type Observational
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date June 2008