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Prostate CancerNCT00335634

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

An observational study of Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, run by University Health Network, Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 70 years
How many people
50 participants
Where
2 sitesCanada
Study dates
Jun 2006to Jul 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Etobicoke General Hospital

    Etobicoke, Ontario, M9V 1R8

  • The Prostate Centre, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the 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.

Keywords
Prostate Cancer, Radical Prostatectomy, Sexual Dysfunction, Intimacy, Adaptation, Psychosocial Oncology
Medical subject headings
Prostatic Neoplasms, Sexual Dysfunction, Physiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Semi-Structured Interview - Patient

    Measured: 3-6 months post-radical prostatectomy

  2. Semi-Structured Interview - Patient

    Measured: 12-15 months post-radical prostatectomy

  3. Semi-Structured Interview - Patient

    Measured: 21-24 months post-radical prostatectomy

  4. Semi-Structured Interview - Partner

    Measured: 3-6 months post-radical prostatectomy

  5. Semi-Structured Interview - Partner

    Measured: 12-15 months post-radical prostatectomy

  6. Semi-Structured Interview - Partner

    Measured: 21-24 months post-radical prostatectomy

  7. Semi-Structured Interview - Couple

    Measured: 3-6 months post-radical prostatectomy

  8. Semi-Structured Interview - Couple

    Measured: 12-15 months post-radical prostatectomy

  9. Semi-Structured Interview - Couple

    Measured: 21-24 months post-radical prostatectomy

Secondary outcomes (21)

  1. 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

    Measured: 3-6 months post-radical prostatectomy

  2. Index of Sexual Life

    Used to assess sexual desire and overall sexual satisfaction in female partners

    Measured: 3-6 months post-radical prostatectomy

  3. Dyadic Adjustment Scale

    Used to measure couple distress

    Measured: 3-6 months post-radical prostatectomy

  4. Hospital Anxiety and Depression Scale

    Used to measure anxiety and depression

    Measured: 3-6 months post-radical prostatectomy

  5. 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

    Measured: 12-15 months post-radical prostatectomy

  6. 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

    Measured: 21-24 months post-radical prostatectomy

  7. Index of Sexual Life

    Used to assess sexual desire and overall sexual satisfaction in female partners

    Measured: 12-15 months post-radical prostatectomy

  8. Index of Sexual Life

    Used to assess sexual desire and overall sexual satisfaction in female partners

    Measured: 21-24 months post-radical prostatectomy

  9. Dyadic Adjustment Scale

    Used to measure couple distress

    Measured: 12-15 months post-radical prostatectomy

  10. Dyadic Adjustment Scale

    Used to measure couple distress

    Measured: 21-24 months post-radical prostatectomy

  11. Hospital Anxiety and Depression Scale

    Used to measure anxiety and depression

    Measured: 12-15 months post-radical prostatectomy

  12. Hospital Anxiety and Depression Scale

    Used to measure anxiety and depression

    Measured: 21-24 months post-radical prostatectomy

  13. Brief Profile of Mood States

    Used to measure emotional distress

    Measured: 3-6 months post-radical prostatectomy

  14. Brief Profile of Mood States

    Used to measure emotional distress

    Measured: 12-15 months post-radical prostatectomy

  15. Brief Profile of Mood States

    Used to measure emotional distress

    Measured: 21-24 months post-radical prostatectomy

  16. Miller Social Intimacy Scale

    Used to measure patient-partner intimacy

    Measured: 3-6 months post-radical prostatectomy

  17. Miller Social Intimacy Scale

    Used to measure patient-partner intimacy

    Measured: 12-15 months post-radical prostatectomy

  18. Miller Social Intimacy Scale

    Used to measure patient-partner intimacy

    Measured: 21-24 months post-radical prostatectomy

  19. Sternberg Triangular Love Scale

    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

    Measured: 3-6 months post-radical prostatectomy

  20. Sternberg Triangular Love Scale

    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

    Measured: 12-15 months post-radical prostatectomy

  21. Sternberg Triangular Love Scale

    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

    Measured: 21-24 months post-radical prostatectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335634
Sponsor's protocol ID
PC-05-0813
Status last verified
Dec 2015
First submitted
8 Jun 2006
Last updated
10 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semi-Structured Interview - Patient (time frame: 3-6 months post-radical prostatectomy). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00335634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.

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