Clinical trial NCT00335634: Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery
Official title: Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Sexual Dysfunction
Keywords: Prostate Cancer
Radical Prostatectomy
Sexual Dysfunction
Intimacy
Adaptation
Psychosocial Oncology
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.

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.

Eligibility 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

Primary outcomes:
measure: Semi-Structured Interview - Patient
timeFrame: 3-6 months post-radical prostatectomy
measure: Semi-Structured Interview - Patient
timeFrame: 12-15 months post-radical prostatectomy
measure: Semi-Structured Interview - Patient
timeFrame: 21-24 months post-radical prostatectomy
measure: Semi-Structured Interview - Partner
timeFrame: 3-6 months post-radical prostatectomy
measure: Semi-Structured Interview - Partner
timeFrame: 12-15 months post-radical prostatectomy
measure: Semi-Structured Interview - Partner
timeFrame: 21-24 months post-radical prostatectomy
measure: Semi-Structured Interview - Couple
timeFrame: 3-6 months post-radical prostatectomy
measure: Semi-Structured Interview - Couple
timeFrame: 12-15 months post-radical prostatectomy
measure: Semi-Structured Interview - Couple
timeFrame: 21-24 months post-radical prostatectomy
Secondary outcomes:
measure: The International Index of Erectile Function
timeFrame: 3-6 months post-radical prostatectomy
measure: Index of Sexual Life
timeFrame: 3-6 months post-radical prostatectomy
measure: Dyadic Adjustment Scale
timeFrame: 3-6 months post-radical prostatectomy
measure: Hospital Anxiety and Depression Scale
timeFrame: 3-6 months post-radical prostatectomy
measure: The International Index of Erectile Function
timeFrame: 12-15 months post-radical prostatectomy
measure: The International Index of Erectile Function
timeFrame: 21-24 months post-radical prostatectomy
measure: Index of Sexual Life
timeFrame: 12-15 months post-radical prostatectomy
measure: Index of Sexual Life
timeFrame: 21-24 months post-radical prostatectomy
measure: Dyadic Adjustment Scale
timeFrame: 12-15 months post-radical prostatectomy
measure: Dyadic Adjustment Scale
timeFrame: 21-24 months post-radical prostatectomy
measure: Hospital Anxiety and Depression Scale
timeFrame: 12-15 months post-radical prostatectomy
measure: Hospital Anxiety and Depression Scale
timeFrame: 21-24 months post-radical prostatectomy
measure: Brief Profile of Mood States
timeFrame: 3-6 months post-radical prostatectomy
measure: Brief Profile of Mood States
timeFrame: 12-15 months post-radical prostatectomy
measure: Brief Profile of Mood States
timeFrame: 21-24 months post-radical prostatectomy
measure: Miller Social Intimacy Scale
timeFrame: 3-6 months post-radical prostatectomy
measure: Miller Social Intimacy Scale
timeFrame: 12-15 months post-radical prostatectomy
measure: Miller Social Intimacy Scale
timeFrame: 21-24 months post-radical prostatectomy
measure: Sternberg Triangular Love Scale
timeFrame: 3-6 months post-radical prostatectomy
measure: Sternberg Triangular Love Scale
timeFrame: 12-15 months post-radical prostatectomy
measure: Sternberg Triangular Love Scale
timeFrame: 21-24 months post-radical prostatectomy
Other outcomes:
Locations:
city: Etobicoke
country: Canada
facility: Etobicoke General Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Prostate Centre, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Andrew G Matthew, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References: