Sexual Health and Relationship Enhancement of patients with Prostate Cancer and their partners

Prostate cancer is the most common male cancer in the Western world. In the
Netherlands, on an annual basis 11100 men are diagnosed on average with
prostate cancer (2010-2013, IKNL. The majority of men diagnosed with prostate
cancer survive for many years, but they may experience adverse effects of the
disease or its treatments. Many effective treatment options are available to
men with prostate cancer, including surgery, hormonal therapy, external-beam
radiotherapy (EBRT), and brachytherapy. Most of these currently available
treatments carry the risk of a number of treatment-related side-effects,
including urinary incontinence, erectile dysfunction (ED), decreased libido and
others that vary, depending on the treatment received. Some men select
treatment based on perceived side effect profiles, frequently focusing on
urinary incontinence and ED. One of the main complications associated with
treatment for prostate cancer is ED. The significance of ED as a complication
following prostate cancer treatment, especially laparoscopic radical
prostatectomy (LRP), lies in the negative impact that it has on patients*
sexual and overall life. In the literature, rates of ED following LRP range
from 25% to 100%. Such variety is associated with pelvic dissection and
conservation of neurovascular structures. Following nerve-sparing LRP, the
impotence rate at academic centers has been shown to be as high as 32% to 38%
and is even greater (60% to 70%) in community-based surgical series. Likewise,
there is a significant incidence of erectile dysfunction (ED) following
external beam radiotherapy and interstitial brachytherapy when patients are
followed for at least 2 years after treatment (23% to 56% and 27% to 53%,
respectively). All forms of prostate cancer therapy carry significant risk of
ED, but patients value sexual function so highly that they are often willing to
choose a therapy that offers a shorter life expectancy but better potency
following treatment. Although the precise estimations of ED secondary to
prostate cancer treatment vary from study to study, more than 50% of men
experience it and consider it upsetting. Many men affected by prostate cancer
and erectile dysfunction experience symptoms of anxiety and depression, with
reduced quality of life directly associated with urinary and sexual body-image
changes that occur after surgery. Partners of these men also experience
considerable psychological distress, with partners reporting anxiety and
depression more often than patients. The difficulties experienced after surgery
can also impact on the couple relationship itself; for instance, erectile
dysfunction is associated with reduced wellbeing and lower levels of dyadic
adjustment in the first year after surgery. Prostate cancer has been described
as a *relationship disease* and it has been established that couples affected
by prostate cancer often have significant unmet psychosexual supportive care
needs around sexual recovery and rehabilitation.
Alongside the pre-treatment informed consent, it is important for physicians to
address post-treatment sexual concerns and supply support and advice on how to
deal with the treatment consequences. Little is known of the patients* point of
view concerning type and timing of sexual counseling.

This study is designed in order to determine the type and timing of sexual
rehabilitation after prostate cancer treatment according to the patient*s and
the patient*s partner*s point of view. Furthermore, it will assess which health
care provider the patient desires for this specific support. Outcome of this
survey will be used to design a quality care improvement based on patient*s
experiences and suggestions.

We will perform a multicenter, cross-sectional study among prostate cancer
patients diagnosed in the past two years or treated in the past two years after
active surveillance at four Dutch centers; Leiden University Medical Centre in
Leiden, Reinier de Graaf Gasthuis in Delft, Diakonessenhuis in Utrecht and Zuwe
Hofpoort hospital in Woerden and of which Leiden University Medical Centre will
be the coordinating center and Reinier de Graaf Gasthuis, Zuwe Hofpoort and
Diakonessenhuis the participating centers. Patients will receive a postal
letter on writing paper from the medical center where treated, explaining the
objectives of the study and a consent form with post-paid return
envelope.(Appendix 1,2) If consent is provided, the patient will receive the
questionnaire, which can be filled out at home. In addition to the specific
questionnaire regarding post-treatment care for sexual concerns, there is the
PQN-R in order to inventory the disease and treatment*s effect on the
relationship. A copy will be provided for the partner (if applicable). Given
our data indicate certain type of intervention regarding sexual counseling for
prostate cancer patients after diagnosis and/or treatment is needed, we will
implement this into the our department of Urology on short notice.


Materials; Questionnaire
The questionnaire was designed by the authors, based on study aim and a review
of the literature in the area. The validated Psy Questionnaire
Netherlands-Relationship Quality (PQN-R) was incorporated for inventory of the
relationship quality, for the use of both patients and partners.(Appendix 3) A
multidisciplinary expert panel, with experience in developing surveys, checked
the questionnaire for comprehensiveness and quality. A patient panel piloted
the questionnaire afterwards.
The questionnaire focuses on the patient*s experiences and satisfaction
regarding current care for sexual issues following prostate cancer treatment.
Moreover, it assesses the timing and type of intervention and by which health
care provider would be the best approach for sexual rehabilitation after
prostate cancer diagnosis and treatment.


Data management:
We will approach every patient that was treated with laparoscopic radical
prostatectomy, brachytherapy, external beam radiotherapy and hormonal therapy
in the past two years with the ability to understand the questionnaire in
Dutch. Furthermore, patients who have been treated for prostate cancer in the
past two years after a period of active surveillance or watchful waiting will
be approached. If applicable, partners of the approached patients will also be
asked to fill out a questionnaire regarding the relationship. Other inclusion
criteria are willingness and informed consent to participate in the study.
Sexual active as well as sexual inactive patients will be enrolled. The
frequency or kind of sexual activity was not part of the inclusion or exclusion
criteria, nor will be the sexual orientation.
Additional data which we will obtain from the status will include age, prostate
cancer staging, PSA level, Gleason score, treatment type and comorbidities.


Sample size:
For the study, we intent to approach 2250 patients and their partners (600
patients from Leiden University Medical Centre in Leiden, around 550 patients
from Reinier de Graaf Gasthuis, 600 patients from Diakonessenhuis and around
500 patients from Zuwe Hofpoort hospital. Patients will be approached who are
or have been under treatment of the outpatient clinic of the Urology department
of the Leiden University Medical Centre in Leiden, Reinier de Graaf Gasthuis,
Diakonessenhuis and Zuwe Hofpoort with clinical, biochemical, radiological or
pathological confirmed prostate cancer, diagnosed within the past 2 years
(accounting back from the last possible oncology registration date of the LUMC,
which is July 2014) or started with treatment in the past 2 years after an
earlier diagnose with initial watchful waiting or active surveillance. We will
exclude patients who passed away or moved abroad. The number of partners who
will provide permission for participation is not predictable.


Statistical analysis:
Quantitative data were analyzed by SPSS release 18 (SPSS Inc., Chicago, IL,
USA). Means of numerical demographic values and the answers to the questions
will be analyzed with frequencies. Bivariate associations between demographic
information and the categorical data will be calculated using the Pearson
chi-square procedure. Associations between numerical data and demographics of
the respondents will be analyzed with the independent sample t-tests. Two-sided
P values < 0.05 were considered statistically significant.


Ethics:
Ethical approval was asked and obtained in June 2015 by local medical ethical
committee at Leiden University Medical Centre, since it concerns a survey with
sensitive questions. For inclusion of patients of other medical centers,
Reinier de Graaf Gasthuis, Diakonessenhuis and Zuwe Hofpoort ethical approval
is required to perform a multicenter study. For the inclusion of the patients,
a letter explaining the study and an informed consent form will be provided
before sending the questionnaire.

Questions from the questionnaire may be confrontational and / or sensitive,
depending entirely on the attitude towards sexuality of the patient. This risk
is mitigated by providing comprehensive information in advance, so the patient
and the partner itself may decide to participate before he / she gets to see
the questionnaire.