Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335634
• Other study ID #: PC-05-0813
• Status: Completed
• Phase: N/A
• First received: June 8, 2006
• Last updated: December 9, 2015
• Start date: June 2006
• Est. completion date: July 2009

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Prostate Cancer
• Prostatic Neoplasms
• Sexual Dysfunction

Locations

Country	Name	City	State
Canada	Etobicoke General Hospital	Etobicoke	Ontario
Canada	The Prostate Centre, Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-Structured Interview - Patient		3-6 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Patient		12-15 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Patient		21-24 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Partner		3-6 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Partner		12-15 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Partner		21-24 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Couple		3-6 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Couple		12-15 months post-radical prostatectomy	No
Primary	Semi-Structured Interview - Couple		21-24 months post-radical prostatectomy	No
Secondary	The International Index of Erectile Function	Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners	3-6 months post-radical prostatectomy	No
Secondary	Index of Sexual Life	Used to assess sexual desire and overall sexual satisfaction in female partners	3-6 months post-radical prostatectomy	No
Secondary	Dyadic Adjustment Scale	Used to measure couple distress	3-6 months post-radical prostatectomy	No
Secondary	Hospital Anxiety and Depression Scale	Used to measure anxiety and depression	3-6 months post-radical prostatectomy	No
Secondary	The International Index of Erectile Function	Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners	12-15 months post-radical prostatectomy	No
Secondary	The International Index of Erectile Function	Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners	21-24 months post-radical prostatectomy	No
Secondary	Index of Sexual Life	Used to assess sexual desire and overall sexual satisfaction in female partners	12-15 months post-radical prostatectomy	No
Secondary	Index of Sexual Life	Used to assess sexual desire and overall sexual satisfaction in female partners	21-24 months post-radical prostatectomy	No
Secondary	Dyadic Adjustment Scale	Used to measure couple distress	12-15 months post-radical prostatectomy	No
Secondary	Dyadic Adjustment Scale	Used to measure couple distress	21-24 months post-radical prostatectomy	No
Secondary	Hospital Anxiety and Depression Scale	Used to measure anxiety and depression	12-15 months post-radical prostatectomy	No
Secondary	Hospital Anxiety and Depression Scale	Used to measure anxiety and depression	21-24 months post-radical prostatectomy	No
Secondary	Brief Profile of Mood States	Used to measure emotional distress	3-6 months post-radical prostatectomy	No
Secondary	Brief Profile of Mood States	Used to measure emotional distress	12-15 months post-radical prostatectomy	No
Secondary	Brief Profile of Mood States	Used to measure emotional distress	21-24 months post-radical prostatectomy	No
Secondary	Miller Social Intimacy Scale	Used to measure patient-partner intimacy	3-6 months post-radical prostatectomy	No
Secondary	Miller Social Intimacy Scale	Used to measure patient-partner intimacy	12-15 months post-radical prostatectomy	No
Secondary	Miller Social Intimacy Scale	Used to measure patient-partner intimacy	21-24 months post-radical prostatectomy	No
Secondary	Sternberg Triangular Love Scale	Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion	3-6 months post-radical prostatectomy	No
Secondary	Sternberg Triangular Love Scale	Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion	12-15 months post-radical prostatectomy	No
Secondary	Sternberg Triangular Love Scale	Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion	21-24 months post-radical prostatectomy	No