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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |