Prostate CancerPROCANNCT02103088
Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners
A study testing Sexual and urological intervention in people with Prostate Cancer, run by Danish Cancer Society at 1 site in Denmark.
Trial summary
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sexual and urological intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Feb 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Patients operated for primary prostate cancer with open or robot-assisted surgery using nerve sparring or non-nerve sparring technique living with a female partner and reported being sexually active before the operation.
Exclusion Criteria:Patients with other cancers (except non-melanoma skin cancer) within 5 years, major psychiatric disorder, abuse of alcohol or drugs, dementia, e.g. Alzheimer's disease and patients, who do not understand or speak Danish. Patients, who reported not being sexually active before the operation and partners who do not understand or speak Danish.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Urology, Rigshospitalet
Copenhagen, Copenhagen Ø, 2100
About this study
Official title: PROCAN: Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners: A Randomized Controlled Intervention Study
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Besides these physical late effects patients operated for PC have a twofold increased risk for depression up to ten years after the diagnosis. To reduce these late effects affecting both patient and partner the investigators have developed a sexual and urological intervention (PROCAN). The intervention is based on epidemiological data, evidence from previous clinical trials, a feasibility study and qualitative explorations among PC patients and partners. The investigators hereby suggest the conduction of a randomized controlled trial to test the effect of the PROCAN intervention on urological and sexual dysfunction, couples adjustment and quality of life. Results of the proposed trial may provide clinicians and decision makers with the evidence needed to optimize rehabilitation after PC.
Read the detailed description
Although the potential negative impact of prostate cancer on sexual and urological function is well documented there is no evidence based and standardized rehabilitation offer available for Danish couples affected by prostate cancer. This study proposal is based on a thorough literature review on PC treatment and late effects and interventions targeting sexual and urological late effects and a qualitative study including interviews with 6 couples affected by PC. The literature review showed that; medical treatment is effective for the treatment of erectile dysfunction, psychosocial intervention may ease sexual problems secondary to operation for prostate cancer and sexual counseling may improve compliance with medical treatment of erectile dysfunction. In regard to treatment of urological dysfunction studies showed that the effect of pelvic floor muscle training is enhanced by follow-up instructions by physiotherapist. Our interview study among patients operated for prostate cancer and their partners indicated a general need and demand for professional help to discuss the changed sexual life. Also studies have shown that health professionals find it difficult to discuss sexual problems with the patients. Medical treatment for erectile dysfunction is prescribed to patients operated for prostate cancer, however the treatment is not offered systematically in all hospitals and furthermore the drugs are sold on the internet.In view of this knowledge we determine that there is a need for studies which include patients systematically offered medical treatment for erectile dysfunction and further is offered sexual counseling and thus focusing on: i) treatment of physical, psychological and social aspects of sexual dysfunction ii) improvement of compliance with the medical treatment for erectile dysfunction and iii) reducing barriers among patients and health professionals for resolving sexual problems secondary to operation for prostate cancer.
The purpose of the PROCAN study is in a randomized design to test the effect of a theory based intervention on sexual and urological dysfunctions secondary to operation for prostate cancer. The PROCAN intervention consists of: i) Digital Video Disc (DVD) instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including up to three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor. The intervention is based on social and cognitive behavioral techniques and techniques derived from sexual therapy and counseling with a psycho-educational approach, in which sexuality is defined as a multidimensional construct involving biological, psychological and social aspects. The intervention is documented and developed in collaboration with urologists, physiotherapists and sexologists. The investigators will enroll patients and partners from the Urological Department Rigshospitalet and randomize 160 couples. Patients and partners will be randomized (1:1) to standard care plus the PROCAN intervention and to standard care (control Group). The investigators hypothesize that the PROCAN intervention will:
- Improve urological and sexual functioning among prostate cancer patients and sexual function and satisfaction among patients and female partners
- Improve the dyadic adjustment and the overall quality of life in prostate cancer patients and their partners
- Reduce the prevalence of depression and anxiety in patients and their partners
- Conditions
- Prostate Cancer
- Being tested
- Sexual and urological intervention
- Keywords
- Prostate cancer, Intervention, Rehabilitation, Couple, Sexology, Urology, Late effects
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual and urological interventionBehavioural
Sexual and urological intervention consisting of: i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor.
| Study group | Role | What they receive |
|---|---|---|
| Sexual and urological intervention | Experimental | Standard care and the PROCAN intervention consisting of i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor. Receives: Behavioral: Sexual and urological intervention |
| Control | No intervention | Standard care consists of:systematic offer of medical treatment for erectile dysfunction, if not contra indicated. The medical treatment will consist of either daily treatment with Cialis 5 mg or phosphodiesterase type 5 inhibitor on demand before sexual activity. Alternatively use of alprostadil as either urethral pin or penile injection. Furthermore standard treatments include preoperative instruction in pelvic floor muscle training, regular outpatient visits and possible referral to rehabilitation in accordance with the rules that apply to the Danish Health legislations. In case of prolonged incontinence the patients may on request be referred to a private practicing physiotherapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function measured by the International Index of Erectile Function (IIEF-15)
To investigate the change in erectile function among patients in intervention- and the control group from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 months and 12 months
Secondary outcomes (8)
Sexual satisfaction measured by IIEF-15
To investigate the change in sexual satisfaction among patients from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Female sexual satisfaction measured by The Female Sexual Function Index (FSFI)
To investigate the change in sexual satisfaction among female partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Female Sexual Distress measured by the Female Sexual Distress Scale (FSDS)
To investigate the change in female sexual distress from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Urological function measured by The Expanded Prostate Cancer Composite Index (EPIC-26)
To investigate the change in urological function among patients from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Marital function measured by The Dyadic Adjustment Scale (DAS)
To investigate the change in marital function among patients and partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Health related quality of life measured by The Short Form Health Survey (SF-36)
To investigate the change in health related quality of life among patients and partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Anxiety measured by The Symptom Check List (SCL-92)
To investigate the change in anxiety among patients and partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Depression measured by The Major Depression Inventory (MDI)
To investigate the change in depressive symptoms among patients and partners partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Measured: Baseline, 8 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2019
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- The Capital Region Research Foundation for Health Research Denmark, Copenhagen University Hospital, Rigshospitalet, Clinic for Sexology and Center for Psychiatry Copenhagen Denmark
- Responsible party
- Principal investigator, Christoffer Johansen, Danish Cancer Society
- Investigators
- Christoffer Johansen, PhD, Dr. Med, Principal investigator, Danish Cancer SocietyRandi V. Karlsen, RN, MEd, Principal investigator, Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103088
- Sponsor's protocol ID
- PROCAN
- Acronym
- PROCAN
- Status last verified
- Feb 2021
- First submitted
- 1 Apr 2014
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROCAN: Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners: A Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT02103088
- Acronym / sponsor ID
- PROCAN / PROCAN
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Intervention, Rehabilitation, Couple, Sexology, Urology, Late effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- The Capital Region Research Foundation for Health Research Denmark, Copenhagen University Hospital, Rigshospitalet, Clinic for Sexology and Center for Psychiatry Copenhagen Denmark
- Study start
- May 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Besides these physical late effects patients operated for PC have a twofold increased risk for depression up to ten years after the diagnosis. To reduce these late effects affecting both patient and partner the investigators have developed a sexual and urological intervention (PROCAN). The intervention is based on epidemiological data, evidence from previous clinical trials, a feasibility study and qualitative explorations among PC patients and partners. The investigators hereby suggest the conduction of a randomized controlled trial to test the effect of the PROCAN intervention on urological and sexual dysfunction, couples adjustment and quality of life. Results of the proposed trial may provide clinicians and decision makers with the evidence needed to optimize rehabilitation after PC.
Detailed description
Although the potential negative impact of prostate cancer on sexual and urological function is well documented there is no evidence based and standardized rehabilitation offer available for Danish couples affected by prostate cancer. This study proposal is based on a thorough literature review on PC treatment and late effects and interventions targeting sexual and urological late effects and a qualitative study including interviews with 6 couples affected by PC. The literature review showed that; medical treatment is effective for the treatment of erectile dysfunction, psychosocial intervention may ease sexual problems secondary to operation for prostate cancer and sexual counseling may improve compliance with medical treatment of erectile dysfunction. In regard to treatment of urological dysfunction studies showed that the effect of pelvic floor muscle training is enhanced by follow-up instructions by physiotherapist. Our interview study among patients operated for prostate cancer and their partners indicated a general need and demand for professional help to discuss the changed sexual life. Also studies have shown that health professionals find it difficult to discuss sexual problems with the patients. Medical treatment for erectile dysfunction is prescribed to patients operated for prostate cancer, however the treatment is not offered systematically in all hospitals and furthermore the drugs are sold on the internet.In view of this knowledge we determine that there is a need for studies which include patients systematically offered medical treatment for erectile dysfunction and further is offered sexual counseling and thus focusing on: i) treatment of physical, psychological and social aspects of sexual dysfunction ii) improvement of compliance with the medical treatment for erectile dysfunction and iii) reducing barriers among patients and health professionals for resolving sexual problems secondary to operation for prostate cancer.
The purpose of the PROCAN study is in a randomized design to test the effect of a theory based intervention on sexual and urological dysfunctions secondary to operation for prostate cancer. The PROCAN intervention consists of: i) Digital Video Disc (DVD) instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including up to three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor. The intervention is based on social and cognitive behavioral techniques and techniques derived from sexual therapy and counseling with a psycho-educational approach, in which sexuality is defined as a multidimensional construct involving biological, psychological and social aspects. The intervention is documented and developed in collaboration with urologists, physiotherapists and sexologists. The investigators will enroll patients and partners from the Urological Department Rigshospitalet and randomize 160 couples. Patients and partners will be randomized (1:1) to standard care plus the PROCAN intervention and to standard care (control Group). The investigators hypothesize that the PROCAN intervention will:
- Improve urological and sexual functioning among prostate cancer patients and sexual function and satisfaction among patients and female partners
- Improve the dyadic adjustment and the overall quality of life in prostate cancer patients and their partners
- Reduce the prevalence of depression and anxiety in patients and their partners
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual and urological intervention | Experimental | Behavioral: Sexual and urological interventionStandard care and the PROCAN intervention consisting of i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor. |
| Control | No intervention | –Standard care consists of:systematic offer of medical treatment for erectile dysfunction, if not contra indicated. The medical treatment will consist of either daily treatment with Cialis 5 mg or phosphodiesterase type 5 inhibitor on demand before sexual activity. Alternatively use of alprostadil as either urethral pin or penile injection. Furthermore standard treatments include preoperative instruction in pelvic floor muscle training, regular outpatient visits and possible referral to rehabilitation in accordance with the rules that apply to the Danish Health legislations. In case of prolonged incontinence the patients may on request be referred to a private practicing physiotherapist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual and urological interventionSexual and urological intervention consisting of: i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor. | Behavioural | Sexual and urological intervention |
Primary outcome
Erectile function measured by the International Index of Erectile Function (IIEF-15)
Time frame: Baseline, 8 months and 12 months
To investigate the change in erectile function among patients in intervention- and the control group from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
8 secondary outcomes
Sexual satisfaction measured by IIEF-15
Time frame: Baseline, 8 and 12 months
Female sexual satisfaction measured by The Female Sexual Function Index (FSFI)
Time frame: Baseline, 8 and 12 months
Female Sexual Distress measured by the Female Sexual Distress Scale (FSDS)
Time frame: Baseline, 8 and 12 months
Urological function measured by The Expanded Prostate Cancer Composite Index (EPIC-26)
Time frame: Baseline, 8 and 12 months
Marital function measured by The Dyadic Adjustment Scale (DAS)
Time frame: Baseline, 8 and 12 months
Health related quality of life measured by The Short Form Health Survey (SF-36)
Time frame: Baseline, 8 and 12 months
Anxiety measured by The Symptom Check List (SCL-92)
Time frame: Baseline, 8 and 12 months
Depression measured by The Major Depression Inventory (MDI)
Time frame: Baseline, 8 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Johansen, PhD, Dr. Med principal investigator
Danish Cancer Society
Randi V. Karlsen, RN, MEd principal investigator
Danish Cancer Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual and urological intervention in people with Prostate Cancer, run by Danish Cancer Society at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Feb 2021. 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 Denmark. 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?
Erectile function measured by the International Index of Erectile Function (IIEF-15) (time frame: Baseline, 8 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.