- Email: [email protected]
Identifying Psychosocial Distress and Stressors Using Distress-screening Instruments in Patients With Localized and Advanced Penile Cancer
Accepted Manuscript Identifying psychosocial distress and stressors using distress-screening instruments in patients with localized and advanced penile cancer D.L. Dräger, C. Protzel, O.W. Hakenberg PII:
S1558-7673(17)30094-0
DOI:
10.1016/j.clgc.2017.04.010
Reference:
CLGC 823
To appear in:
Clinical Genitourinary Cancer
Received Date: 10 December 2016 Revised Date:
4 April 2017
Accepted Date: 9 April 2017
Please cite this article as: Dräger D, Protzel C, Hakenberg O, Identifying psychosocial distress and stressors using distress-screening instruments in patients with localized and advanced penile cancer, Clinical Genitourinary Cancer (2017), doi: 10.1016/j.clgc.2017.04.010. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
ACCEPTED MANUSCRIPT Identifying psychosocial distress and stressors using distress-screening
RI PT
instruments in patients with localized and advanced penile cancer
Dräger DL, Protzel C, Hakenberg OW
M AN U
SC
Department of Urology, University of Rostock
Correspondence: Désirée Louise Dräger, MD, Department of Urology, University of Schillingallee
35,
18057
Rostock,
Germany;
E-mail:
TE D
Rostock,
EP
[email protected]
AC C
Competing interests: The authors declare that they have no conflict of interests
Key words: Distress, psychological stress, penile cancer, psychosocial need of care
Count: 2406 words, 242 abstract, 4 figures and tables, 19 references
2
ACCEPTED MANUSCRIPT MICROABSTRACT The psychological stress of patients with penile cancer arises from the cancer diagnosis per se and the corresponding consequences of treatment (loss of body integrity and sexual function). In addition, there is cancer-specific distress e.g. fear of
RI PT
metastasis, progress, relapse or death. To examine the effects of curative and palliative treatment on the psychological well-being of patients with localized or advanced penile cancer using screening questionnaires and determining the
SC
consecutive need of psychosocial care was the aim of this study. We undertook a
M AN U
prospective analysis of patients with penile cancer undergoing surgical treatment or chemotherapy. The result of this study was that patients with penile cancer have increased psychological stress and consequently an increased need of psychosocial
AC C
EP
TE D
care due to the potentially mutilating surgery.
3
ACCEPTED MANUSCRIPT ABSTRACT BACKGROUND: To examine the effects of treatment on the psychological well-being of patients with localized or advanced penile cancer using screening questionnaires and determining the consecutive need of psychosocial care was the purpose of this study.
RI PT
Penile cancer is a rare but highly aggressive malignancy. The psychological stress of patients with penile cancer arises from the cancer diagnosis per se and the corresponding consequences of treatment. In addition, there is cancer-specific
MATERIAL
AND
M AN U
stress of penile cancer patients are rare.
SC
distress e.g. fear of metastasis, progress, relapse or death. Studies on the psychosocial
METHODS: We undertook a prospective analysis of patients with
penile cancer who underwent surgical treatment or chemotherapy in the period from 08/2014 to 10/2016 in our department. Patients were evaluated by using
TE D
standardized questionnaires for stress screening and the identification of the need for psychosocial care (NCCN-DT and Hornheider SI) as well as by assessing the actual
EP
use of psycho-social support.
RESULTS: The average stress level was 4.5. Of all patients, 42.5% showed increased
AC C
care needs at the time of the survey. Younger patients, patients undergoing chemotherapy and patients with a recurrence were significantly more integrated with psychosocial care systems. 67%of all patients received inpatient psychosocial care. CONCLUSION: Due to the potentially mutilating surgery, patients with penile cancer have increased psychological stress and consequently an increased need of
4
ACCEPTED MANUSCRIPT psychosocial care. Therefore, the emotional stress in these patients should be recognized and support based on interdisciplinary collaboration should be offered. INTRODUCTION
RI PT
Penile cancer is a rare malignancy in Europe and the US (0.4-0.6% of all malignancies in men). However, there is significant variation of incidence and mortality between different countries, continents and ethnicities. While incidence and mortality are
SC
generally low in industrialized countries they are much higher in South East Asia, parts of Africa and South America. The incidence in Germany is 0.9/100,000 men per
M AN U
year amounting to 805 new cases and 165 penile-cancer related deaths in 2011 [1]. In Brazil penile cancer accounts for 1-2% of all male malignancies and it is also much more common in China, Vietnam and Uganda. The age peak is 55-65 years, but 20% of patients are younger than 40 years and 7% are under 30 years of age [1].
TE D
Risk factors include chronic inflammation (balanoposthitis) and phimosis. Infection with human papilloma virus (HPV, especially types 16 and 18) is associated with
EP
some histological variants of penile cancer (basaloid and warty) but not others. Highrisk HPV are found in 40-60% of all penile cancers and HPV-associated penile cancer
AC C
seems to take a somewhat less aggressive course with a better prognosis [2]. Treatment is usually by local surgery, occasionally by radiotherapy, both of which can be mutilating. Additional surgery of the inguinal lymph nodes can lead to additional morbidity with scrotal and/or leg lymphedema and wound complications [3]. The psychological burden of patients with penile cancer results from the cancer diagnosis itself and correlates with the treatment effects (loss of body integrity and
5
ACCEPTED MANUSCRIPT sexual function). Cancer-specific fears concerning the possibility of metastasis, relapse or death are added to this. The chance of cure in penile cancer is given in localized tumor stages and in those with limited regional lymph node metastasis but
RI PT
requires surgery and often adjuvant chemotherapy [4]. Quite often the diagnosis is made relatively late. Shame, fear, denial and guilt can lead to a delayed diagnosis; 15-50% of all penile cancers are diagnosed within one
SC
year of the onset of the first symptoms [5]. If treatment is delayed or insufficient for fear of mutilating consequences and potential complications recurrence may occur
M AN U
which substantially reduces the chance of cure [6].
So far, research into the psychosocial stress burden of men with penile cancer is quite deficient which is largely due to its low incidence. However, it is clear that these men
TE D
will suffer increased mental stress and will consequently have an increased need for psychosocial care [4]. This disease- and treatment related stress burden represents special reactions and does not fulfil the criteria of a mental disorder. The emotional
EP
stress in these patients should be recognized but not pathologized and appropriate psychosocial support should be given. The forms and contents of the mental burden
AC C
are also dependent on various other factors such as life history, identity development, relationships and family constellations [7]. The purpose of this study was to examine the current psychosocial distress and psychosocial need of care in patients with localized and advanced penile carcinoma.
MATERIAL AND METHODS
6
ACCEPTED MANUSCRIPT In this study, we examined patients with localized or advanced penile cancer (n = 40), who underwent surgical (n = 29) or systemic treatment by chemotherapy (n = 11) over a period of 22 months in our institution. During this recruitment phase, we included all penile cancer patients irrespective of tumor stage (localized, locally
RI PT
advanced, metastatic) and also irrespective of whether treatment was with curative intent or palliative. Participants were recruited during the preadmission consultation
SC
when patients were consented for surgery or chemotherapy. All consecutive patients treated during this period were included. The purpose of the survey was explained
M AN U
to all patients and all patients agreed to participate in the study.
All patients were native German speakers, without any evidence of cognitive disorders in the interview and did not have a history of any psychiatric disorders. All patients gave written informed consent for participation in this study and internal
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review board approval had been obtained.
Patients were asked to answer two questionnaires regarding their psychosocial stress
EP
and psychosocial need for care (Hornheider screening instrument [8] and NCCN Distress Thermometer [9]). Demographic and medical data (age, gender, tumour
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stage, treatment and medical history) were obtained from the patient database and medical records.
The NCCN Distress Thermometer (NCCN DT) is a screening tool for cancer patients. It is easy to handle and rates the current stress experience on a scale from 1 to 10, 10 being the worst. Since doctors often discuss the emotional side effects of cancer in much less detail than the physical consequences, such screening tools make it easier for patients express the emotional effects caused by the diagnosis, symptoms and
7
ACCEPTED MANUSCRIPT treatment of cancer. It is a valid measure over the entire course of the disease from diagnosis to follow-up and can be well used in urology patients [9]. The NCCN DT also includes a list of problems with a total of 36 items in five
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different domains which can result in stress. These domains are: practical problems (e.g. housing situation), family problems (e.g. access to children), emotional problems (e.g. sadness), spiritual problems (e.g. loss of faith) and physical problems (e.g. pain).
SC
All these items are answered as dichotomous "yes" or "no" options. The problem list also provides information as to which health care professional a patient should be
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referred to. A score of 5 is internationally regarded as an indicator that a patient is stressed and needs support. The NCCN DT has been reported to have a sensitivity of 84% and a specificity of 47% for detection of a moderate burden of anxiety/depression and of 97% and 41%, respectively, when anxiety/depression
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burden is high (HADS cut-off > 8 or > 10, respectively) [9]. The Hornheider screening instrument (HSI) was developed to identify patients in
EP
need of care quickly and reliably at first contact. It consists of seven questions that measure the psychological stress with eight items. Physical and mental state as well
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as level of information about the disease and its treatment are recorded each in a three-point scale. In addition, the presence of stress burden independent of the disease relating to relatives and resources (e.g. the presence of a caregiver or the possibility of daytime rest) are noted. Each patient is also asked for an estimation of his/her "subjective psychosocial need".
The time needed to respond to this
questionnaire is usually less than one minute. For the evaluation, the point values of the response categories are counted. If the total value is greater than the
8
ACCEPTED MANUSCRIPT predetermined threshold, the patient is considered in need of care, e.g. with an HSIsum value ≥ 4. In comparison to the German version of the HADS (thresholds of fear > 10 and/or depression score > 8), the HSI sum value of 4 or greater has a sensitivity
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of 0.68 or 0.62, respectively, with a specificity of 0.76 or 0.75, respectively [8]. These screening tools are short psychological tests, which are helpful in identifying patients who are in need of psychosocial care. Thus, they can serve a pragmatic
SC
approach to subgroup selection.
In our study, all questionnaires were self-administered. The results were recorded
M AN U
electronically (EXCEL) and analyzed statistically. The HSI was evaluated by means of the HSI sum value (threshold ≥4). For the NCCN DT a value of 5 was taken as signifying significant stress. Descriptive statistics (IBM SPSS Statistics 22) were used
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to characterize the demographic, clinical and distress variables. Student’s t-test was used for the comparison of means and Spearman’s correlation for associations
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RESULTS
EP
between variables.
Between June 1, 2014 and April 30, 2016, a total of 40 patients with penile cancer underwent surgery (n = 29) or chemotherapy (n = 11) in our department. All patients underwent pretherapeutic screening with the two questionnaires (HSI, NCCN-DT). The demographic data and disease characteristics are given in table 1. The median patient age was 64 years (SD 13.6, range 31-88 years). The mean rate of self-reported distress was 4.5 (SD 2.3) (fig.1). A cut-off point of 5 on the NCCN-DT was used for implementing psychosocial care.
9
ACCEPTED MANUSCRIPT 47.5% of patients had an increased stress level independent of age, treatment and tumor stage. Patients under 65 years had a significantly higher need for psychosocial care, while the differences in the NCCN-DT were not significant (4.8 vs. 4.2; fig. 1). Patients who received chemotherapy had a moderately elevated level of stress
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(NCCN-DT 3.8).
The main stressors identified by the NCCN-DT were sorrow (44%), voiding
SC
problems (30%), anxiety (36%), exhaustion (32%), limitations in mobility (32%), sadness (24%), pain (24%) and sexual dysfunction (16%). There was an age-related
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change in these stressors. In patients under 50 years emotional stressors dominated while in the group over 65 years somatic aspects were more pronounced (tab. 2). With regard to the need for psychosocial care and the desire for psychosocial
TE D
support, there were no significant differences between age and treatment groups. The HSI results, however, showed a discrepancy in the self-reported need for support. This was significantly lower (p< 0.001) than the need as assessed by the HSI
EP
(42.5% over all age groups versus 5% as by self-reported need in the HSI) (fig. 1), i.e. significant underreporting. All patient groups had an increased need for care
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regardless of treatment, age and tumor stage. Patients with cancer recurrence indicated significantly increased psychosocial care needs compared to patients with first treatment of the primary tumour (50% vs. 38%, p< 0,001). Also, younger patients had significantly higher care needs than older patients (53% vs. 37%, p< 0,001). However, younger patients, patients undergoing chemotherapy and patients with recurrence were also significantly more integrated in psychosocial care systems (p < 0,01) (fig. 2). It was not possible to compare results with the radicalty of surgery since
10
ACCEPTED MANUSCRIPT these patients underwent a number of different surgical procedures all of which were ‘radical’ in providing negative surgical margins.
The majority of patients with
surgery had organ-preserving surgery, often with reconstruction, and only one
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patient underwent a complete penectomy (fig. 1 and 2). There was a weak but significant positive correlation between the scores of the HSI and the NCCN-DT (Spearman r² = 0.493). Thus, high values in the NCCN-DT were
SC
associated with high values in the HSI.
67% of patients identified as being in need of psychosocial care received in- or
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outpatient psychosocial assistance and the majority of all patients felt that the offer as well as the actual support were helpful in terms of coping.
DISCUSSION
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Our evaluation of patients with penile cancer not surprisingly elevated stress levels with an increased need of psychosocial care. Distress is a multifactorial negative
EP
emotional experience of psychological (cognitive, behavioral, emotional), social, and/or spiritual origin that may interfere with the ability to cope effectively with the
AC C
disease, its physical and treatment-related consequences. Distress extends along a continuum, ranging from common normal feelings of vulnerability, sadness and fear to problems that can become overwhelming and disabling. Distress arises when stressful events are perceived by the patient as unmanageable, either consciously or unconsciously. Psychosocial stress has many potential effects, especially in cancer patients in whom can result in lower survival rates. Also,
11
ACCEPTED MANUSCRIPT significant distress is a risk factor for non-compliance and non-adherence to treatment and poorer compliance with follow-up [9] [10]. Less than 50% of distressed cancer patients are actually identified and referred for
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psychosocial help [11, 12]. Thus, under-recognition of psychological needs by the primary oncology team is a problem. Patients often do not volunteer information about their distress and physicians often do not specifically ask [13].
SC
Ficarra et al. in 2000 [14] reported that 53.3% of all studied penile cancer patients showed symptoms of mental disorders; in their cohort, two patients had a post-
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traumatic stress disorder (PTSD), 25% showed avoidance behavior and 40% impaired well-being measured by the Global Health Questionnaire (GHQ). Romero et al. also in penile cancer patients reported a measurable impairment of well-being in 37.5%
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and increased anxiety levels in 31% [15]. In contrast D'Ancona et al. using the Hospital Anxiety and Depression Score (HADS) could not demonstrate reduced well-being in their penile cancer patients [16].
EP
There are limitations in the comparability of these studies. All these studies were
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retrospective with low patient numbers using different psychometric instruments with different thresholds for defining abnormalities. However, it seems clear that several studies including our own have found increased anxiety and distress levels in penile cancer patients.
This is not surprising since genital mutilations strongly negatively correlate with quality of life [14]. In penile cancer, depression has been estimated to occur in up to 50% of patients [4]. In contrast, in our study only one patient reported a depressive
12
ACCEPTED MANUSCRIPT mood while, 3 patients reported the loss of daily activities and 6 suffered from insomnia both of which may be interpreted as a symptom of depression. Obviously, sexual function is affected by penile cancer treatment and it has been
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reported that 70% of patients experience a negative impact on sexuality [4]. This was confirmed by Ficarra et al. (2000) reporting reduced sexual function scores (2.1 across all treatment groups) [14] and by D`Ancona et al. reporting a moderately to severely
sexual dysfunction which seems relatively low.
SC
reduced sexual function in 36% of patients [16]. In our patients, only 16% reported
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The identification of patients with a psychosocial risk profile is important in clinical practice but still underused. The use standardized and validated questionnaires routinely in patients at risk is helpful [13].
Psychological interventions may be
TE D
needed especially after fundamental changes in body image for example following penile surgical procedures [17].
Our study confirms that patients with penile cancer can have significant
EP
psychological distress, often higher than with other genito-urinary tumor entities.
AC C
Currently, however, there are no standardized tools for defining psychosocial distress. Due to its high acceptance, its brevity and practicality we consider the NCCN-DT a good screening tool. The NCCN-DT has been widely used in different groups of cancer patients. Future research will have to identify perhaps better screening tools but until then this tool can be used in routine clinical practice [18, 19]. The limitations of our study are that the patient cohort was small and heterogenous and that it represents the north-east German cultural context. The degree of
13
ACCEPTED MANUSCRIPT underreporting seen in our patients may be different in other regional, national and cultural settings.
CONCLUSIONS
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For men, the penis is of course a focus of sexual identity. Defects or mutilations due to penile cancer treatment cause psychological distress in a substantial number of
SHORT CLINICAL PRACTICE POINTS •
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and adequate psychoncological intervention.
SC
patients. These can be identified by practical screening tools which allows for early
Due to the potentially mutilating surgery, patients with penile cancer have
psychosocial care
The emotional stress in these patients can be recognized by screening tools
EP
and support based on psychological interventions can be offered
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•
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increased psychological stress and consequently an increased need of
14
ACCEPTED MANUSCRIPT
The authors declare that they have no conflict of interests
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REFERENCES
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ACKNOWLEDGEMENTS
[1] Parkin DM, Whelan SL, Ferlay J et al. (2002). Cancer incidence in Five continents.
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IARC Scientific Publications No. 155, Lyon
[2] Rubin MA, Kleter B, Zhou M et al. (2001). Detection and typing of human papillomavirus DNA in penile carcinoma: evidence for multiple independent pathways of penile carcinogenesis. Am J Pathol 159: 1211-1218 [3] Hakenberg OW, Compérat EM, Minhas S, Necchi A, Protzel C, Watkin N (2014).
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EAU guidelines on penile cancer: 2014 update. Eur Urol 67(1):142-50 [4] Maddineni SB, Lau MM, Sangar VK. Identifying the needs of penile cancer sufferers: A systematic review of the quality of life, psychosexual and psychosocial
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literature in penile cancer. BMC Urol. 2009; 9: 8 [5] Reynard J, Brewster S, Biers S (2013). Oxford Handbook of Urology. Chapter 7:
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Urological neoplasia: Penile cancer – clinical management. Oxford University Press; 374-376
[6] Protzel C, Alcaraz A, Horenblas S et al. (2009). Lymphadenectomy in the surcigal management of penile cancer. Eur Urol 55: 1075-1088 [7] Orom H, Nelson CJ, Unterwood W III, Homish DL, Kapoor DA. Factors associated with emotional distress in newly diagnosed prostate cancer patients. Psychology 2015; 24(11):1416-1422 [8] Strittmatter G, Mawick R, Tilkorn M. Entwicklung und klinischer Einsatz von Screening-Instrumenten zur Identifikation betreuungsbedürftiger Tumorpatienten.
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ACCEPTED MANUSCRIPT In: Bullinger M, Siegrist J, Ravens-Sieberer U. Lebensqualitätsforschung aus medizinpsychologischer und – soziologischer Perspektive. Jahrbuch der Medizinischen Psychologie 2000; 18: 59-75 [9] Mehnert A, Müller D, Lehmann C, Koch U. Die deutsche Version des NCCN
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Distress Thermometers – Empirische Prüfung eines Screening-Instruments zur Erfassung psychosozialer Belastung bei Krebspatienten. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 2006; 54(3): 213-223
[10] Chambers SK, Zajdlewick L, Youlden D et al. The validity of distress
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thermometer in prostate cancer populations. Psychooncology 2014; 23: 195-203
[11] Partridge AH, Wang PS, Winer EP, Avorn J. Nonadherence to adjuvant
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tamoxifen therapy in women with primary breast cancer. J Clin Oncol 2003; 21: 602-
[12] Carmack CL, Basen-Engquist K, Gritz ER. Survivors at higher risk for adverse late outcomes due to psychosocial and behavioral risk factors. Cancer Epidemiol
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Biomarkers Prev 2011; 20: 2068-2077
[13] Kadan-Lottick NS, Vanderwerker LC, Block SD, et al. Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the coping
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with cancer study. Cancer 2005; 104: 2872-2881 [14] Ficarro V, Righetti R, DÁmico A, Pilloni S, Balzarro M, Schiavone D, Malossini G, Mobilio G. General state of health and psychological well-being in patients after
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surgery for urological malignant neoplasms. Urol Int 2000, 65: 130-134 [15] Romero FR, Romero KR, Mattos MA, Garcia CR, Fernandes Rde C, Perez MD. Sexual function after partial penectomy for penile cancer. Urology 2005, 66 (6): 12921295
[16] D´Ancona CA, Botega NJ, De Moraes C, Lavoura NS Jr, Santos JK, Rodrigues Netto N Jr. Quality of life after partial penectomy for penile carcinoma. Urology 2005, 66 (6): 1292-1295 [17] Cassileth BR, Lusk EJ, Tenaglia AN (1983). Patients´perceptions of the cosmetic impact of melanoma resection. Plast Reconstr Surg; 71 (1): 73-75
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ACCEPTED MANUSCRIPT [18] Bultz BD, Groff SL, Fitch M, Blais MC, Howes J, Levy K, Mayer C. Implementing screening for distress, the 6th vital sign: a Canadian strategy for changing practice. Psychooncology. 2011; 20 (5): 463-469 [19] Carlson LE, Waller A, Mitchell AJ. Screening for distress and unmet needs in
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patients with cancer: review and recommendations. J Clin Oncol. 2012 10; 30 (11):
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1160-1177
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FIGURES AND TABLES
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TAB. 1: Baseline characteristics of the included patients
TAB. 2: Age-related stratification of main stressors (Distress Thermometer, cut-off ≥ 5)
18
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ACCEPTED MANUSCRIPT
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EP
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FIG. 1: Average stress level measured by Distress Thermometer (cut-off ≥ 5)
FIG. 2: Need, demand und use of psychosocial support measured by HSI (cut-off ≥4). All patient groups showed an increased need for care regardless of treatment, age and tumor stage. Younger patients, patients undergoing chemotherapy, and patients with a recurrence are significantly more integrated with psychosocial care systems (p < 0,01).
S1558-7673(17)30094-0
DOI:
10.1016/j.clgc.2017.04.010
Reference:
CLGC 823
To appear in:
Clinical Genitourinary Cancer
Received Date: 10 December 2016 Revised Date:
4 April 2017
Accepted Date: 9 April 2017
Please cite this article as: Dräger D, Protzel C, Hakenberg O, Identifying psychosocial distress and stressors using distress-screening instruments in patients with localized and advanced penile cancer, Clinical Genitourinary Cancer (2017), doi: 10.1016/j.clgc.2017.04.010. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
ACCEPTED MANUSCRIPT Identifying psychosocial distress and stressors using distress-screening
RI PT
instruments in patients with localized and advanced penile cancer
Dräger DL, Protzel C, Hakenberg OW
M AN U
SC
Department of Urology, University of Rostock
Correspondence: Désirée Louise Dräger, MD, Department of Urology, University of Schillingallee
35,
18057
Rostock,
Germany;
E-mail:
TE D
Rostock,
EP
[email protected]
AC C
Competing interests: The authors declare that they have no conflict of interests
Key words: Distress, psychological stress, penile cancer, psychosocial need of care
Count: 2406 words, 242 abstract, 4 figures and tables, 19 references
2
ACCEPTED MANUSCRIPT MICROABSTRACT The psychological stress of patients with penile cancer arises from the cancer diagnosis per se and the corresponding consequences of treatment (loss of body integrity and sexual function). In addition, there is cancer-specific distress e.g. fear of
RI PT
metastasis, progress, relapse or death. To examine the effects of curative and palliative treatment on the psychological well-being of patients with localized or advanced penile cancer using screening questionnaires and determining the
SC
consecutive need of psychosocial care was the aim of this study. We undertook a
M AN U
prospective analysis of patients with penile cancer undergoing surgical treatment or chemotherapy. The result of this study was that patients with penile cancer have increased psychological stress and consequently an increased need of psychosocial
AC C
EP
TE D
care due to the potentially mutilating surgery.
3
ACCEPTED MANUSCRIPT ABSTRACT BACKGROUND: To examine the effects of treatment on the psychological well-being of patients with localized or advanced penile cancer using screening questionnaires and determining the consecutive need of psychosocial care was the purpose of this study.
RI PT
Penile cancer is a rare but highly aggressive malignancy. The psychological stress of patients with penile cancer arises from the cancer diagnosis per se and the corresponding consequences of treatment. In addition, there is cancer-specific
MATERIAL
AND
M AN U
stress of penile cancer patients are rare.
SC
distress e.g. fear of metastasis, progress, relapse or death. Studies on the psychosocial
METHODS: We undertook a prospective analysis of patients with
penile cancer who underwent surgical treatment or chemotherapy in the period from 08/2014 to 10/2016 in our department. Patients were evaluated by using
TE D
standardized questionnaires for stress screening and the identification of the need for psychosocial care (NCCN-DT and Hornheider SI) as well as by assessing the actual
EP
use of psycho-social support.
RESULTS: The average stress level was 4.5. Of all patients, 42.5% showed increased
AC C
care needs at the time of the survey. Younger patients, patients undergoing chemotherapy and patients with a recurrence were significantly more integrated with psychosocial care systems. 67%of all patients received inpatient psychosocial care. CONCLUSION: Due to the potentially mutilating surgery, patients with penile cancer have increased psychological stress and consequently an increased need of
4
ACCEPTED MANUSCRIPT psychosocial care. Therefore, the emotional stress in these patients should be recognized and support based on interdisciplinary collaboration should be offered. INTRODUCTION
RI PT
Penile cancer is a rare malignancy in Europe and the US (0.4-0.6% of all malignancies in men). However, there is significant variation of incidence and mortality between different countries, continents and ethnicities. While incidence and mortality are
SC
generally low in industrialized countries they are much higher in South East Asia, parts of Africa and South America. The incidence in Germany is 0.9/100,000 men per
M AN U
year amounting to 805 new cases and 165 penile-cancer related deaths in 2011 [1]. In Brazil penile cancer accounts for 1-2% of all male malignancies and it is also much more common in China, Vietnam and Uganda. The age peak is 55-65 years, but 20% of patients are younger than 40 years and 7% are under 30 years of age [1].
TE D
Risk factors include chronic inflammation (balanoposthitis) and phimosis. Infection with human papilloma virus (HPV, especially types 16 and 18) is associated with
EP
some histological variants of penile cancer (basaloid and warty) but not others. Highrisk HPV are found in 40-60% of all penile cancers and HPV-associated penile cancer
AC C
seems to take a somewhat less aggressive course with a better prognosis [2]. Treatment is usually by local surgery, occasionally by radiotherapy, both of which can be mutilating. Additional surgery of the inguinal lymph nodes can lead to additional morbidity with scrotal and/or leg lymphedema and wound complications [3]. The psychological burden of patients with penile cancer results from the cancer diagnosis itself and correlates with the treatment effects (loss of body integrity and
5
ACCEPTED MANUSCRIPT sexual function). Cancer-specific fears concerning the possibility of metastasis, relapse or death are added to this. The chance of cure in penile cancer is given in localized tumor stages and in those with limited regional lymph node metastasis but
RI PT
requires surgery and often adjuvant chemotherapy [4]. Quite often the diagnosis is made relatively late. Shame, fear, denial and guilt can lead to a delayed diagnosis; 15-50% of all penile cancers are diagnosed within one
SC
year of the onset of the first symptoms [5]. If treatment is delayed or insufficient for fear of mutilating consequences and potential complications recurrence may occur
M AN U
which substantially reduces the chance of cure [6].
So far, research into the psychosocial stress burden of men with penile cancer is quite deficient which is largely due to its low incidence. However, it is clear that these men
TE D
will suffer increased mental stress and will consequently have an increased need for psychosocial care [4]. This disease- and treatment related stress burden represents special reactions and does not fulfil the criteria of a mental disorder. The emotional
EP
stress in these patients should be recognized but not pathologized and appropriate psychosocial support should be given. The forms and contents of the mental burden
AC C
are also dependent on various other factors such as life history, identity development, relationships and family constellations [7]. The purpose of this study was to examine the current psychosocial distress and psychosocial need of care in patients with localized and advanced penile carcinoma.
MATERIAL AND METHODS
6
ACCEPTED MANUSCRIPT In this study, we examined patients with localized or advanced penile cancer (n = 40), who underwent surgical (n = 29) or systemic treatment by chemotherapy (n = 11) over a period of 22 months in our institution. During this recruitment phase, we included all penile cancer patients irrespective of tumor stage (localized, locally
RI PT
advanced, metastatic) and also irrespective of whether treatment was with curative intent or palliative. Participants were recruited during the preadmission consultation
SC
when patients were consented for surgery or chemotherapy. All consecutive patients treated during this period were included. The purpose of the survey was explained
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to all patients and all patients agreed to participate in the study.
All patients were native German speakers, without any evidence of cognitive disorders in the interview and did not have a history of any psychiatric disorders. All patients gave written informed consent for participation in this study and internal
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review board approval had been obtained.
Patients were asked to answer two questionnaires regarding their psychosocial stress
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and psychosocial need for care (Hornheider screening instrument [8] and NCCN Distress Thermometer [9]). Demographic and medical data (age, gender, tumour
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stage, treatment and medical history) were obtained from the patient database and medical records.
The NCCN Distress Thermometer (NCCN DT) is a screening tool for cancer patients. It is easy to handle and rates the current stress experience on a scale from 1 to 10, 10 being the worst. Since doctors often discuss the emotional side effects of cancer in much less detail than the physical consequences, such screening tools make it easier for patients express the emotional effects caused by the diagnosis, symptoms and
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ACCEPTED MANUSCRIPT treatment of cancer. It is a valid measure over the entire course of the disease from diagnosis to follow-up and can be well used in urology patients [9]. The NCCN DT also includes a list of problems with a total of 36 items in five
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different domains which can result in stress. These domains are: practical problems (e.g. housing situation), family problems (e.g. access to children), emotional problems (e.g. sadness), spiritual problems (e.g. loss of faith) and physical problems (e.g. pain).
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All these items are answered as dichotomous "yes" or "no" options. The problem list also provides information as to which health care professional a patient should be
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referred to. A score of 5 is internationally regarded as an indicator that a patient is stressed and needs support. The NCCN DT has been reported to have a sensitivity of 84% and a specificity of 47% for detection of a moderate burden of anxiety/depression and of 97% and 41%, respectively, when anxiety/depression
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burden is high (HADS cut-off > 8 or > 10, respectively) [9]. The Hornheider screening instrument (HSI) was developed to identify patients in
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need of care quickly and reliably at first contact. It consists of seven questions that measure the psychological stress with eight items. Physical and mental state as well
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as level of information about the disease and its treatment are recorded each in a three-point scale. In addition, the presence of stress burden independent of the disease relating to relatives and resources (e.g. the presence of a caregiver or the possibility of daytime rest) are noted. Each patient is also asked for an estimation of his/her "subjective psychosocial need".
The time needed to respond to this
questionnaire is usually less than one minute. For the evaluation, the point values of the response categories are counted. If the total value is greater than the
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ACCEPTED MANUSCRIPT predetermined threshold, the patient is considered in need of care, e.g. with an HSIsum value ≥ 4. In comparison to the German version of the HADS (thresholds of fear > 10 and/or depression score > 8), the HSI sum value of 4 or greater has a sensitivity
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of 0.68 or 0.62, respectively, with a specificity of 0.76 or 0.75, respectively [8]. These screening tools are short psychological tests, which are helpful in identifying patients who are in need of psychosocial care. Thus, they can serve a pragmatic
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approach to subgroup selection.
In our study, all questionnaires were self-administered. The results were recorded
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electronically (EXCEL) and analyzed statistically. The HSI was evaluated by means of the HSI sum value (threshold ≥4). For the NCCN DT a value of 5 was taken as signifying significant stress. Descriptive statistics (IBM SPSS Statistics 22) were used
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to characterize the demographic, clinical and distress variables. Student’s t-test was used for the comparison of means and Spearman’s correlation for associations
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RESULTS
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between variables.
Between June 1, 2014 and April 30, 2016, a total of 40 patients with penile cancer underwent surgery (n = 29) or chemotherapy (n = 11) in our department. All patients underwent pretherapeutic screening with the two questionnaires (HSI, NCCN-DT). The demographic data and disease characteristics are given in table 1. The median patient age was 64 years (SD 13.6, range 31-88 years). The mean rate of self-reported distress was 4.5 (SD 2.3) (fig.1). A cut-off point of 5 on the NCCN-DT was used for implementing psychosocial care.
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ACCEPTED MANUSCRIPT 47.5% of patients had an increased stress level independent of age, treatment and tumor stage. Patients under 65 years had a significantly higher need for psychosocial care, while the differences in the NCCN-DT were not significant (4.8 vs. 4.2; fig. 1). Patients who received chemotherapy had a moderately elevated level of stress
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(NCCN-DT 3.8).
The main stressors identified by the NCCN-DT were sorrow (44%), voiding
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problems (30%), anxiety (36%), exhaustion (32%), limitations in mobility (32%), sadness (24%), pain (24%) and sexual dysfunction (16%). There was an age-related
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change in these stressors. In patients under 50 years emotional stressors dominated while in the group over 65 years somatic aspects were more pronounced (tab. 2). With regard to the need for psychosocial care and the desire for psychosocial
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support, there were no significant differences between age and treatment groups. The HSI results, however, showed a discrepancy in the self-reported need for support. This was significantly lower (p< 0.001) than the need as assessed by the HSI
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(42.5% over all age groups versus 5% as by self-reported need in the HSI) (fig. 1), i.e. significant underreporting. All patient groups had an increased need for care
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regardless of treatment, age and tumor stage. Patients with cancer recurrence indicated significantly increased psychosocial care needs compared to patients with first treatment of the primary tumour (50% vs. 38%, p< 0,001). Also, younger patients had significantly higher care needs than older patients (53% vs. 37%, p< 0,001). However, younger patients, patients undergoing chemotherapy and patients with recurrence were also significantly more integrated in psychosocial care systems (p < 0,01) (fig. 2). It was not possible to compare results with the radicalty of surgery since
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ACCEPTED MANUSCRIPT these patients underwent a number of different surgical procedures all of which were ‘radical’ in providing negative surgical margins.
The majority of patients with
surgery had organ-preserving surgery, often with reconstruction, and only one
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patient underwent a complete penectomy (fig. 1 and 2). There was a weak but significant positive correlation between the scores of the HSI and the NCCN-DT (Spearman r² = 0.493). Thus, high values in the NCCN-DT were
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associated with high values in the HSI.
67% of patients identified as being in need of psychosocial care received in- or
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outpatient psychosocial assistance and the majority of all patients felt that the offer as well as the actual support were helpful in terms of coping.
DISCUSSION
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Our evaluation of patients with penile cancer not surprisingly elevated stress levels with an increased need of psychosocial care. Distress is a multifactorial negative
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emotional experience of psychological (cognitive, behavioral, emotional), social, and/or spiritual origin that may interfere with the ability to cope effectively with the
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disease, its physical and treatment-related consequences. Distress extends along a continuum, ranging from common normal feelings of vulnerability, sadness and fear to problems that can become overwhelming and disabling. Distress arises when stressful events are perceived by the patient as unmanageable, either consciously or unconsciously. Psychosocial stress has many potential effects, especially in cancer patients in whom can result in lower survival rates. Also,
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ACCEPTED MANUSCRIPT significant distress is a risk factor for non-compliance and non-adherence to treatment and poorer compliance with follow-up [9] [10]. Less than 50% of distressed cancer patients are actually identified and referred for
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psychosocial help [11, 12]. Thus, under-recognition of psychological needs by the primary oncology team is a problem. Patients often do not volunteer information about their distress and physicians often do not specifically ask [13].
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Ficarra et al. in 2000 [14] reported that 53.3% of all studied penile cancer patients showed symptoms of mental disorders; in their cohort, two patients had a post-
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traumatic stress disorder (PTSD), 25% showed avoidance behavior and 40% impaired well-being measured by the Global Health Questionnaire (GHQ). Romero et al. also in penile cancer patients reported a measurable impairment of well-being in 37.5%
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and increased anxiety levels in 31% [15]. In contrast D'Ancona et al. using the Hospital Anxiety and Depression Score (HADS) could not demonstrate reduced well-being in their penile cancer patients [16].
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There are limitations in the comparability of these studies. All these studies were
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retrospective with low patient numbers using different psychometric instruments with different thresholds for defining abnormalities. However, it seems clear that several studies including our own have found increased anxiety and distress levels in penile cancer patients.
This is not surprising since genital mutilations strongly negatively correlate with quality of life [14]. In penile cancer, depression has been estimated to occur in up to 50% of patients [4]. In contrast, in our study only one patient reported a depressive
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ACCEPTED MANUSCRIPT mood while, 3 patients reported the loss of daily activities and 6 suffered from insomnia both of which may be interpreted as a symptom of depression. Obviously, sexual function is affected by penile cancer treatment and it has been
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reported that 70% of patients experience a negative impact on sexuality [4]. This was confirmed by Ficarra et al. (2000) reporting reduced sexual function scores (2.1 across all treatment groups) [14] and by D`Ancona et al. reporting a moderately to severely
sexual dysfunction which seems relatively low.
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reduced sexual function in 36% of patients [16]. In our patients, only 16% reported
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The identification of patients with a psychosocial risk profile is important in clinical practice but still underused. The use standardized and validated questionnaires routinely in patients at risk is helpful [13].
Psychological interventions may be
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needed especially after fundamental changes in body image for example following penile surgical procedures [17].
Our study confirms that patients with penile cancer can have significant
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psychological distress, often higher than with other genito-urinary tumor entities.
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Currently, however, there are no standardized tools for defining psychosocial distress. Due to its high acceptance, its brevity and practicality we consider the NCCN-DT a good screening tool. The NCCN-DT has been widely used in different groups of cancer patients. Future research will have to identify perhaps better screening tools but until then this tool can be used in routine clinical practice [18, 19]. The limitations of our study are that the patient cohort was small and heterogenous and that it represents the north-east German cultural context. The degree of
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ACCEPTED MANUSCRIPT underreporting seen in our patients may be different in other regional, national and cultural settings.
CONCLUSIONS
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For men, the penis is of course a focus of sexual identity. Defects or mutilations due to penile cancer treatment cause psychological distress in a substantial number of
SHORT CLINICAL PRACTICE POINTS •
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and adequate psychoncological intervention.
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patients. These can be identified by practical screening tools which allows for early
Due to the potentially mutilating surgery, patients with penile cancer have
psychosocial care
The emotional stress in these patients can be recognized by screening tools
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and support based on psychological interventions can be offered
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•
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increased psychological stress and consequently an increased need of
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The authors declare that they have no conflict of interests
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ACKNOWLEDGEMENTS
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EAU guidelines on penile cancer: 2014 update. Eur Urol 67(1):142-50 [4] Maddineni SB, Lau MM, Sangar VK. Identifying the needs of penile cancer sufferers: A systematic review of the quality of life, psychosexual and psychosocial
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[6] Protzel C, Alcaraz A, Horenblas S et al. (2009). Lymphadenectomy in the surcigal management of penile cancer. Eur Urol 55: 1075-1088 [7] Orom H, Nelson CJ, Unterwood W III, Homish DL, Kapoor DA. Factors associated with emotional distress in newly diagnosed prostate cancer patients. Psychology 2015; 24(11):1416-1422 [8] Strittmatter G, Mawick R, Tilkorn M. Entwicklung und klinischer Einsatz von Screening-Instrumenten zur Identifikation betreuungsbedürftiger Tumorpatienten.
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ACCEPTED MANUSCRIPT In: Bullinger M, Siegrist J, Ravens-Sieberer U. Lebensqualitätsforschung aus medizinpsychologischer und – soziologischer Perspektive. Jahrbuch der Medizinischen Psychologie 2000; 18: 59-75 [9] Mehnert A, Müller D, Lehmann C, Koch U. Die deutsche Version des NCCN
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surgery for urological malignant neoplasms. Urol Int 2000, 65: 130-134 [15] Romero FR, Romero KR, Mattos MA, Garcia CR, Fernandes Rde C, Perez MD. Sexual function after partial penectomy for penile cancer. Urology 2005, 66 (6): 12921295
[16] D´Ancona CA, Botega NJ, De Moraes C, Lavoura NS Jr, Santos JK, Rodrigues Netto N Jr. Quality of life after partial penectomy for penile carcinoma. Urology 2005, 66 (6): 1292-1295 [17] Cassileth BR, Lusk EJ, Tenaglia AN (1983). Patients´perceptions of the cosmetic impact of melanoma resection. Plast Reconstr Surg; 71 (1): 73-75
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ACCEPTED MANUSCRIPT [18] Bultz BD, Groff SL, Fitch M, Blais MC, Howes J, Levy K, Mayer C. Implementing screening for distress, the 6th vital sign: a Canadian strategy for changing practice. Psychooncology. 2011; 20 (5): 463-469 [19] Carlson LE, Waller A, Mitchell AJ. Screening for distress and unmet needs in
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FIGURES AND TABLES
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TAB. 1: Baseline characteristics of the included patients
TAB. 2: Age-related stratification of main stressors (Distress Thermometer, cut-off ≥ 5)
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FIG. 1: Average stress level measured by Distress Thermometer (cut-off ≥ 5)
FIG. 2: Need, demand und use of psychosocial support measured by HSI (cut-off ≥4). All patient groups showed an increased need for care regardless of treatment, age and tumor stage. Younger patients, patients undergoing chemotherapy, and patients with a recurrence are significantly more integrated with psychosocial care systems (p < 0,01).