RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
NCT00541047
Gastrointestinal Complications, Genital Diseases
Kelowna, British Columbia, Canada
View Trial DetailsNCT Number: 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.
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Notify Me35 year–70 year
All sexes
Observational
Etobicoke General Hospital, Etobicoke, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3-6 months post-radical prostatectomy
Time frame: 12-15 months post-radical prostatectomy
Time frame: 21-24 months post-radical prostatectomy
Time frame: 3-6 months post-radical prostatectomy
Time frame: 12-15 months post-radical prostatectomy
Time frame: 21-24 months post-radical prostatectomy
Time frame: 3-6 months post-radical prostatectomy
Time frame: 12-15 months post-radical prostatectomy
Time frame: 21-24 months post-radical prostatectomy
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
Time frame: 3-6 months post-radical prostatectomy
Used to assess sexual desire and overall sexual satisfaction in female partners
Time frame: 3-6 months post-radical prostatectomy
Used to measure couple distress
Time frame: 3-6 months post-radical prostatectomy
Used to measure anxiety and depression
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
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
Time frame: 12-15 months post-radical prostatectomy
Used to assess sexual desire and overall sexual satisfaction in female partners
Time frame: 21-24 months post-radical prostatectomy
Used to assess sexual desire and overall sexual satisfaction in female partners
Time frame: 12-15 months post-radical prostatectomy
Used to measure couple distress
Time frame: 21-24 months post-radical prostatectomy
Used to measure couple distress
Time frame: 12-15 months post-radical prostatectomy
Used to measure anxiety and depression
Time frame: 21-24 months post-radical prostatectomy
Used to measure anxiety and depression
Time frame: 3-6 months post-radical prostatectomy
Used to measure emotional distress
Time frame: 12-15 months post-radical prostatectomy
Used to measure emotional distress
Time frame: 21-24 months post-radical prostatectomy
Used to measure emotional distress
Time frame: 3-6 months post-radical prostatectomy
Used to measure patient-partner intimacy
Time frame: 12-15 months post-radical prostatectomy
Used to measure patient-partner intimacy
Time frame: 21-24 months post-radical prostatectomy
Used to measure patient-partner intimacy
Time frame: 3-6 months post-radical prostatectomy
Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion
Time frame: 12-15 months post-radical prostatectomy
Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion
Time frame: 21-24 months post-radical prostatectomy
Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion
University Health Network, Toronto
Other
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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