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Prostate CancerBSHRNCT02640131

A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study

A study testing Biomedical Component and Psychosocial Component in people with Prostate Cancer and Erectile Dysfunction, run by University Health Network, Toronto at 1 site 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 burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biomedical Component and Psychosocial Component
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteCanada
Study dates
Jan 2014to May 2017
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • scheduled for a Radical Prostatectomy at the Princess Margaret Cancer Centre(open, laparoscopic, robotic) for the first-line treatment of prostate cancer regardless of clinical stage of disease
  • are hormone and/or chemotherapy-naïve
  • have a sexual partner (heterosexual or homosexual) for at least the past 6 months
  • are 18 years of age or older
  • Partners of men who meet the above criteria and are 18 years of age or older

Who cannot join

  • the patient or partner lacks English proficiency
  • the patient is on nitrate therapy or has other contra-indications to phosphodiesterase type 5 inhibitors (PDE5i's)
  • the patient does not have a sexual partner
  • the patient or partner has a medical condition that would preclude safe sexual activity
  • the patient has had previous treatment for PC
  • the patient has previously and regularly used sexual aids/devices during the course of sexual activity

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Prostate Centre, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.

Read the detailed description

Previous Research: The prevalence of sexual dysfunction (SD) after prostate cancer surgery, coupled with the severity of impact and lack of successful intervention, make SD one of the most substantial health-related quality of life burdens in all of cancer survivorship. In 2012, 21,000 men will be added to the pool of Canadian prostate cancer (PC) survivors. Approximately 70% of men will suffer SD post-surgery and 60% will experience significant distress in response to SD. Similarly, partners may experience even greater distress than patients. Research examining the nature of the distress reveals that the significance of SD extends beyond the ability to have an erection, and includes guilt, depression, anxiety, anger, and reductions in intimacy. Unfortunately, there are no reported interventions that have been successful in reducing the impact of SD on long term couple health-related quality of life.

Project Description: Men and their partners need an effective intervention to help them adapt to sexual dysfunction following prostate cancer surgery. In addressing this need we propose an innovative biomedical-psychosocial Intervention that emphasizes: 1) multidisciplinary intervention teams; 2) the active participation of the partner; and 3) a broad-spectrum medical, psychological, and social approach. The treatment goal of the intervention is to promote intimacy and optimal sexual health in affected couples. This is a preliminary study designed to determine the feasibility of running a large scale randomized controlled trial comparing the new biomedical-psychosocial intervention to an attention control condition.

Impact and Relevance: The burden of sexual dysfunction after prostate cancer surgery is responsible for the single greatest impact on patient/partner health-related quality of life; substantially more so than concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is a great need for progressive and distributable sexual health rehabilitation interventions designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial intervention is ultimately found beneficial, it will result in: 1) an empirically-based intervention that helps patients/partners maintain optimal health-related quality of life after prostate cancer surgery, and 2) a highly structured protocol and manualized intervention that is translatable to other treatment groups (e.g. radiation therapy) and University/Community-based hospitals.

Being tested
Biomedical Component, Psychosocial Component, Attention Control
Keywords
prostate cancer, radical prostatectomy, survivorship, quality of life, erectile dysfunction, sexual dysfunction, feasibility study
Medical subject headings
Prostatic Neoplasms, Erectile Dysfunction, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biomedical ComponentBehavioural

    Bio-medical: The bio-medical component includes an appointment with urologist pre-operatively and 5 follow-up appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices.

  • Psychosocial ComponentBehavioural

    Psychosocial: aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive standardized sexual health counselor (SexHC) counseling and manualized support.

  • Attention ControlBehavioural

    Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) at 3-4, 7-8, and 12-13 months post radical prostatectomy (RP). Couples will receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: Nutrition, Exercise, and You (CPC) manual (a patient self-help manual written by the Princess Margaret Prostate Centre team). The core topics discussed during the counselling sessions include: preparation for immediate post-RP recovery, Kegel exercises, nutrition and prostate cancer (PC), exercise and PC, and maintaining healthy lifestyle change.

Study groups in NCT02640131
Study groupRoleWhat they receive
BSHR InterventionExperimentalCouples will attend 30-minute clinic consultations with an Urologist and a Sexual Health Counsellor and receive session-specific chapters of the Kindness, Intimacy, Sexuality and Satisfaction manual over the course of the intervention. The BSHR Intervention involves two complementary components; the bio-medical, and the psychosocial. The bio-medical component for both arms intervention includes an urologist consultation at a pre-operative appointment and 5 f/u appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices. The psychosocial component aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive sexual health counseling and manualized support.
Receives: Behavioral: Biomedical Component; Behavioral: Psychosocial Component
Attention ControlActive comparatorSurvivorship Counseling: Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) and receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: "Nutrition, Exercise, and You Manual". The bio-medical component is the same in both arms. The core topics discussed during over 7 counseling sessions include: preparation for immediate post-surgery recovery, Kegel exercises, nutrition and prostate cancer, exercise and prostate cancer, and maintaining healthy lifestyle change.
Receives: Behavioral: Biomedical Component; Behavioral: Attention Control

What is being measured

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

  1. Miller Social Intimacy Scale (MSIS)

    Miller Social Intimacy Scale (MSIS):MSIS is a 17-item measure of the maximum level of intimacy currently experienced is used in this study. Each question has a scale of 1-10 with a higher score representing higher level of intimacy.

    Measured: At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

Secondary outcomes (6)

  1. International Index of Erectile Function (IIEF)

    International Index of Erectile Function (IIEF) is validated as a brief, easily administered, patient-reported diagnostic tool for men as a measure for male optimal sexual health for Bio-medical Responders and Bio-medical Non-Responders. IIEF has 15 items in all with a scale from 0(1) to 5. Higher number indicates a better sexual function.

    Measured: At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

  2. Female Sexual Function Inventory (FSFI)

    Female Sexual Function Inventory (FSFI): the FSFI is a brief, 19-item self-report measure of female sexual function that provides scores on six domains of sexual function (Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain) as well as a total score. The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Higher score indicates a better sexual function.

    Measured: At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

  3. Hospital Anxiety and Depression Scale (HADS)

    Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression that participants are experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each question has a scale of 0 to 3 and the total score can be calculated for the two domains (anxiety and depression) by adding the scores together. For each domain, a score of 0-7 = Normal level of anxiety/depression; a score of 8-10 = borderline case of anxiety/depression; 11-21 = case of anxiety/depression.

    Measured: At least one week prior to radical prostatectomy; 13-14 months post-radical prostatectomy

  4. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)

    Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) is used to measure participants' satisfaction with Erectile Dysfunction Treatment. EDITS has 11 items with a scale from 1 to 5. Higher number indicates a higher satisfaction level.

    Measured: 13-14 months post-radical prostatectomy

  5. Sexual Health Rehabilitation Record

    *investigator designed

    Measured: 3-4 months post-radical prostatectomy;7-8 months post-radical prostatectomy;12-13 months post-radical prostatectomy

  6. Expanded Prostate Cancer Index Composite (EPIC)

    EPIC is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. The version we used contains 26 item and the 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-itemscale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL (Health-Related Quality of Life).designed to evaluate patient function and bother after prostate cancer treatment.

    Measured: At least 1 week prior to radical prostatectomy; 13-14 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 posted28 Dec 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2017
  4. Study completionMay 2017

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02640131
Sponsor's protocol ID
701840
Other IDs
701840
Acronym
BSHR
Status last verified
Jun 2018
First submitted
28 May 2014
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Biomedical Component and Psychosocial Component in people with Prostate Cancer and Erectile Dysfunction, run by University Health Network, Toronto at 1 site 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 5 inclusion and 6 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Miller Social Intimacy Scale (MSIS) (time frame: At least 1 week prior to radical prostatectomy; 13-14 months post-radical prostatectomy). 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 NCT02640131.

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 6 Jun 2018.

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