NCT00335634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

3.1 years

First QC Date

June 8, 2006

Last Update Submit

December 9, 2015

Conditions

Prostate CancerErectile Dysfunction Following Radical ProstatectomySexual Dysfunction

Keywords

Prostate CancerRadical ProstatectomySexual DysfunctionIntimacyAdaptationPsychosocial Oncology

Outcome Measures

Primary Outcomes (9)

  • Semi-Structured Interview - Patient

    3-6 months post-radical prostatectomy

  • Semi-Structured Interview - Patient

    12-15 months post-radical prostatectomy

  • Semi-Structured Interview - Patient

    21-24 months post-radical prostatectomy

  • Semi-Structured Interview - Partner

    3-6 months post-radical prostatectomy

  • Semi-Structured Interview - Partner

    12-15 months post-radical prostatectomy

  • Semi-Structured Interview - Partner

    21-24 months post-radical prostatectomy

  • Semi-Structured Interview - Couple

    3-6 months post-radical prostatectomy

  • Semi-Structured Interview - Couple

    12-15 months post-radical prostatectomy

  • Semi-Structured Interview - Couple

    21-24 months post-radical prostatectomy

Secondary Outcomes (21)

  • The International Index of Erectile Function

    3-6 months post-radical prostatectomy

  • Index of Sexual Life

    3-6 months post-radical prostatectomy

  • Dyadic Adjustment Scale

    3-6 months post-radical prostatectomy

  • Hospital Anxiety and Depression Scale

    3-6 months post-radical prostatectomy

  • The International Index of Erectile Function

    12-15 months post-radical prostatectomy

  • +16 more secondary outcomes

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Etobicoke General Hospital

Etobicoke, Ontario, M9V 1R8, Canada

Location

The Prostate Centre, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Andrew G Matthew, PhD, C.Psych

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 12, 2006

Study Start

June 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

CA(2)