Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners
Information source: Danish Cancer Society
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Sexual and urological intervention (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: Danish Cancer Society Official(s) and/or principal investigator(s): Christoffer Johansen, PhD, Dr. Med, Principal Investigator, Affiliation: Danish Cancer Society Randi V. Karlsen, RN, MEd, Principal Investigator, Affiliation: Danish Cancer Society
Overall contact: Randi V Karlsen, RN, MEd, Phone: 0045 35257665, Email: randi@cancer.dk
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. 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.
Clinical Details
Official title: PROCAN: Sexual and Urological Rehabilitation to Men Operated for Prostate Cancer and Their Partners: A Randomized Controlled Intervention Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Erectile function measured by the International Index of Erectile Function (IIEF-15)
Secondary outcome: Sexual satisfaction measured by IIEF-15Female sexual satisfaction measured by The Female Sexual Function Index (FSFI) Female Sexual Distress measured by the Female Sexual Distress Scale (FSDS) Urological function measured by The Expanded Prostate Cancer Composite Index (EPIC-26) Marital function measured by The Dyadic Adjustment Scale (DAS) Health related quality of life measured by The Short Form Health Survey (SF-36) Anxiety measured by The Symptom Check List (SCL-92) Depression measured by The Major Depression Inventory (MDI)
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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Randi V Karlsen, RN, MEd, Phone: 0045 35257665, Email: randi@cancer.dk
Department of Urology, Rigshospitalet, Copenhagen, Copenhagen Ø 2100, Denmark; Recruiting Randi V Karlsen, RN, MEd, Phone: 0045 35257665, Email: randi@cancer.dk Per Bagi, Dr. Med, Principal Investigator
Additional Information
Starting date: May 2014
Last updated: August 4, 2015
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