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
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 |
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.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Etobicoke General Hospital | Etobicoke | Ontario |
Canada | The Prostate Centre, Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
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 |
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