Original Article Oncol Res Treat 2016;39:186–192 DOI: 10.1159/000445307
Received: February 09, 2016 Accepted: March 09, 2016 Published online: March 30, 2016
Symptoms and Needs of Head and Neck Cancer Patients at Diagnosis of Incurability – Prevalences, Clinical Implications, and Feasibility of a Prospective Longitudinal Multicenter Cohort Study Bernd Alt-Epping a Wiebke Seidel b Jeannette Vogt c Anja Mehnert d Michael Thomas e Birgitt van Oorschot f Hendrik Wolff b Henning Schliephake g Martin Canis h Leif H. Dröge i Friedemann Nauck a Florian Lordick c on behalf of the Arbeitsgemeinschaft Palliativmedizin (APM) of the German Cancer Society (DKG) a Department
of Palliative Medicine, University Medical Center Göttingen, Göttingen, Germany; August University Göttingen, Göttingen, Germany; c University Cancer Center Leipzig, Leipzig, Germany; d Department of Medical Psychology and Medical Sociology, University Hospital Leipzig, Leipzig, Germany; e Thoraxklinik, University of Heidelberg, Heidelberg, Germany; f Interdisciplinary Department of Palliative Medicine, University Hospital Würzburg, Würzburg, Germany; g Department of Oral and Maxillofacial Surgery, University Medical Center Göttingen, Göttingen, Germany; h Department of Ear, Nose and Throat Surgery, University Medical Center Göttingen, Göttingen, Germany; i Department of Radiotherapy and Radiation Oncology, University Medical Center Göttingen, Göttingen, Germany b Georg
Keywords Symptoms · Psychosocial needs · Early assessment · Incurability · Feasibility · Screening Summary Background: Little is known about the physical symptoms and psychosocial burden of patients at the time of diagnosis of an incurable situation, although cancer treatment guidelines demand early assessment and integration of palliative care concepts, beginning from the diagnosis of incurability. Methods: Therefore, we initiated a prospective longitudinal multicenter cohort study assessing the symptoms and needs of patients suffering from incurable cancer (various entities), from the time of diagnosing incurability (i.e., before palliative anticancer treatment was initiated) and in 3-monthly intervals thereafter, by using validated self-reporting tools. Here, we focus on patients with head and neck cancer and present preliminary results on symptoms and need prevalences, on clinical implications, and on the feasibility of a methodologically complex assessment procedure in a particularly vulnerable study population. Results: 22 patients Bernd Alt-Epping and Wiebke Seidel contributed equally to this manuscript.
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completed the first visit. The Eastern Cooperative Oncology Group (ECOG) performance scores and most physical symptoms and psychosocial items varied between the extremes, from a virtually uncompromised condition to extremely perceived symptoms and needs. If intense face-to-face study support was provided, the study concept proved to be feasible, despite the complexity of assessment, problems in interdisciplinary and patient communication, comorbidities, and early death from complications. Conclusions: The striking variability in the perceived symptom and need intensities requires a highly individualized approach. For clinical purposes, a less complex screening procedure would be desirable, in order to enable a routine, early and comprehensive support, including palliative care services. © 2016 S. Karger GmbH, Freiburg
Introduction The debate on how to improve symptom control and psychosocial care for patients suffering from incurable cancer has been dominated by the question of when during the course of disease
PD Dr. Bernd Alt-Epping M.D. Department of Palliative Medicine, University Medical Center Göttingen Georg August University Robert Koch Str. 40, 37075 Göttingen, Germany
[email protected]
Table 1. Assessment tools
National Comprehensive Cancer Network (NCCN) distress thermometer (German version)
a single-item visual analogue scale ranging from 0 (= no distress) to 10 (= extreme distress) to quantify the global level of distress [10, 11]
The Functional Assessment of Chronic Illness Therapy (FACT) Questionnaire (General = FACT-G, head and neck module = FACT-H&N)
describes categories of physical, social/family, emotional and functional well-being in general and in head and neck cancer conditions, using a sum score ranging from 0 (= worst) to 148 (= best quality of life) [12]
Schedule for the Evaluation of Individual Quality of Life (SEIQoL-Q)
individual appraisal of the importance of specific domains, and respective contentment [13, 14]
Patient Health Questionnaire-4 (PHQ-4)
ultra-brief measure of depression and anxiety as concurrent psychiatric comorbidity [15]
Supportive Care Needs Survey (SCNS-SF-34-G, modified)
assessment of day-to-day supportive care needs [16]
Table 2. Patient characteristics (case report form) (n = 22)
Characteristic
n
%
Mean age Gender distribution
60.6 years (range 29–82 years) male female
– 16 6
– 72.7 27.2
Family status
living in partnership married divorced single widowed head and neck squamous cell carcinoma angiosarcoma of the scalp cutaneous squamous cell carcinoma of the scalp
12 11 3 4 4 20 1 1
54.5 50.0 13.6 18.1 18.1 90.9 4.5 4.5
inoperable primary tumor inoperable local recurrence distant metastases both distant metastases and inoperable tumor surgery radiation therapy systemic therapy none (only symptom-guided therapy) others > 24 months 12–24 months 6–12 months 0–6 months
6 12 4 11 16 14 10 6 none none 5 13 4
27.2 54.5 18.1 50.0 72.7 63.6 45.4 27.2 0 0 22.7 59.1 18.1
Physician’s perspective on whether the patient is reflecting and accepting incurability
patients reflecting incurability patients accepting incurability
20 19
90.9 86.3
Patient’s understanding of prognosis
cure prolonged life maintained/improved quality of life both quality and length of life present
2 none 5 14 1
9.1 0 22.7 63.6 4.5
advance directive power of attorney
10 10
45.4 45.4
Histology
Criteria defining incurability/ tumor stage at presentation
Preceding anticancer therapies (multiple answers possible)
Physician’s estimated prognosis at first visit
Psycho-oncological support at first visit Advance directive or power of attorney being addressed before first visit
(specialized) palliative care services should be involved. Several studies have evaluated the multifaceted beneficial effects of early palliative care interventions initiated right at the moment when incurability has been diagnosed [1–3]. This, in turn, has led to updated recommendations in clinical practice guidelines [4, 5]. There
are several prevalence studies assessing symptoms and needs during the late course of the disease, for instance, in in-patient palliative care and hospice units [6, 7] or in other end-of-life scenarios, focusing on physical symptoms like pain, anorexia, or dyspnea. Remarkably, there are only very few data on symptom prevalences
Head and Neck Cancer Patients at Diagnosis of Incurability
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during the earlier phases of an (otherwise incurable) disease [8], for instance, at the time of diagnosing incurability. A large singlecenter survey [9] demonstrated that 15.8% of all cancer patients were classified as having palliative care needs. Of those, almost one-third (28.3%) suffered from head and neck cancer; this cancer entity implied the highest need prevalences of all cancer entities. Especially in this group of patients, the combination of both physical symptoms and psychosocial distress was estimated to be prominent. Therefore, the Palliative Medicine Working Group (APM) of the German Cancer Society (DKG) initiated a nationwide multicenter prospective longitudinal cohort study, aiming at determining the symptom burden and psychosocial needs in patients just being diagnosed as having incurable cancer (i.e., before palliative anticancer treatment has started) and in 3-monthly intervals thereafter, in order to better understand the eventual complex demands on structural support (e.g., palliative care services). The Göttingen study site focused explicitly on patients diagnosed with head and neck cancer (as a paradigmatically burdensome disease). Here, we present first assessment results on symptom prevalences and psychosocial needs at the first visit, their clinical implications, and feasibility data of a methodologically complex assessment procedure in a particularly vulnerable study population.
Fig. 1. ECOG score distribution.
Methods The study concept was developed by task force members of the APM of the DKG, and the study conduct was funded by the DKG. After providing written and oral patient information and obtaining written informed consent for participation, demographic and clinical data were documented on a case report form (CRF) and updated according to assessment intervals. A set of validated assessment tools (table 1), all being established in oncology, psycho-oncology, and psychosocial medicine, was selected and exerted in order to achieve the broadest possible scope on all quality-of-life (QoL) and needs categories whilst maintaining practicability and the patients’ acceptance. For Göttingen patients diagnosed with head and neck cancer, ‘incurability’ was defined as inoperable local primary tumor or relapse, or metastatic disease. This study was approved by the local ethics authorities (no. 3/11/13).
Results From 01/2015 until 10/2015, 23 patients were included and assessed. One 87-year-old female patient resigned during first assessment, so 22 patients completed the first visit and were subjected to evaluation. Demographic and CRF Data Of those 22 patients, 16 were male and 6 were female (mean age 60.6 years, range 29–82 years). Histology comprised head and neck squamous cell carcinoma (HNSCC) in 20 patients, 1 patient with angiosarcoma of the scalp, and 1 patient with cutaneous squamous cell carcinoma (SCC) of the scalp with local infiltration of the parotid gland (table 2).
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Fig. 2. Distribution of the NCCN distress thermometer scores (0–10) at the first study visit.
ECOG Performance Score The majority of the recruited patients appeared in an overall good performance status (Eastern Cooperative Oncology Group (ECOG) score 0–1: 14 of 22 patients; 63.6%), as assessed by the study personnel. In contrast, 5 patients presented in compromised conditions (ECOG score 3–4; 22.7%) even at the time of diagnosis of incurability (fig. 1). NCCN DistressThermometer By using the National Comprehensive Cancer Network (NCCN) distress thermometer, most patients reported a substantial burden of distress even at the time of diagnosis of incurability. 12 out of 22 patients (54.5%) reported distress levels of 7 or above at the first study visit (fig. 2). Functional Assessment of Chronic Illness Therapy (FACT-G, FACT-H&N) The Functional Assessment of Chronic Illness Therapy Head and Neck Module (FACT-H&N) total score ranges from 0 (worst) to 148 (best quality of life). Here, the mean total score was 87.7. General physical items, like lack of energy (GP1), feeling ill (GP6), pain (GP4), and even being forced to spend time in bed (GP7), applied to a relevant number of patients. Pain, for instance,
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Patient Health Questionnaire-4 (PHQ-4) An elevated level of depression and anxiety was found in half of the patients (6 and 5 patients with moderately to severely positive overall PHQ-4 score, respectively). The mean score was 5.4 (mild to moderate) on a scale from 0 (none) to 12 (severe). The anxiety and depression subscales show moderate emphasis on anxiety (12 vs. 9 patients).
Fig. 3. Distribution of ‘pain’ prevalences and intensities at the first visit.
Supportive Care Needs Survey (SCNS-SF-34, Modified) The assessment of day-to-day support, using a modified SCNSSF-34 questionnaire, revealed needs for addressing fears and worries in a relevant number of patients, similar to symptoms like pain and fatigue, and issues around advance directives or a power of attorney. These needs were described to have already largely been met. More information about the course of the disease, about palliative care offers, partnership, sexual implications of the disease, or spiritual care was not considered necessary by the vast majority of the patients.
Feasibility Fig. 4. Distribution of ‘dry mouth’ prevalences and intensities at the first visit.
was found to be prevalent ‘quite a bit’ or ‘very much’ in 9 of 22 patients (40.9%), whereas another 9 patients described pain to be a problem ‘not at all’ or ‘a little bit’ (fig. 3). This scoring pattern – from virtually no feeling of being affected to extremely perceived suffering – was found in all of the above-named physical items (fig. 3). Physical items specific for head and neck disease, like being unable to eat the favored foods (H&N1), being able to eat solid foods (H&N11), or suffering from a dry mouth (H&N2), were almost uniformly present even at the first visit (fig. 4). Smoking cigarettes or drinking alcohol was completely denied (‘not at all’) in 12 and 17 of 22 patients, respectively (fig. 4). Emotional aspects showed tendencies addressing dissatisfaction with the general living conditions, but not particularly with respect to the illness: 9 patients stated to be not at all content with the quality of their life right now (GF7), but 9 patients stated not to worry about dying at all (GE5) or to lose hope at all (11 patients). Schedule for the Evaluation of Individual QoL (SEIQoL-Q) The majority of patients described family and partnership (friends to a lesser extent) to be most important, similar to one’s own physical and emotional health, independent living, or the ‘at home’ situation. Items like job, spirituality/religion, or social life/ social events were considered to be of little or no importance, though. Patients were content with their own social situation (family, partnership, and friends) to a similar extent, but they were not at all content with their health condition. Money and finances were described to be of moderate importance, and patients were content with their own financial situation in a similarly restrained way, as compared to the social items.
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This first analysis demonstrates that even a complex self-assessment of physical symptoms and psychosocial needs is, in general, feasible to perform on particularly vulnerable patients, as represented by patients suffering from advanced head and neck cancer. Feasibility, however, is compromised by a number of factors that were identified during this study phase: complexity of assessment, patient communication, comorbidities, and interdisciplinary communication during recruitment and follow-up. Complexity of Assessment The assessment tools were selected in order to provide insights into several QoL domains, physical ones and beyond. 1 patient felt overstrained during her first assessment and withdrew her consent to proceed (and was therefore lost for evaluation). Another patient completed the first visit but refused follow-up visits. The complexity of items, the required capacity of self-reflection and introspection especially when psychosocial aspects were assessed, the length of time requiring full attention, the logical structure of analogue scales, and compromised social, educational and intellectual conditions especially in patients suffering from this particular cancer entity prevented the patients from completing the assessment on their own. Instead, the patients required time-consuming support during the assessment and explanations about the content and methodology of the scales and questionnaires by direct communication. Patient Communication A relevant number of patients (n = 5) depended on tracheostomy, following radical surgery or applied in protective intention to patients suffering from congestive tumor growth. For these patients, communication by telephone, even for making appointments, was impossible, and face-to-face communication was re-
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quired. These circumstances, in combination with the described complexity of the assessment, impeded the previously intended assessment by mail, fax, or online. Comorbidities Many of the patients diagnosed with incurable head and neck cancer suffered from concomitant diseases that prevented full assessment and therefore study inclusion. These comorbidities were in part cancer related (e.g., a patient with sinusoidal squamous cell carcinoma became blind and deaf due to optic nerve compression and inner ear affection), or were related to (underprivileged) social circumstances, like Korsakov encephalopathy or characteristic infections (e.g., first diagnosis of an overt pulmonary tuberculosis). Other comorbidities were independent of the underlying cancer or social situation, like a preexisting dementia. In total, 7 of 22 patients (31.8%) died before the planned second visit (i.e., within 3 months after study inclusion). Interdisciplinary Communication during Recruitment and Follow-Up Numerous departments are involved in the multimodal treatment of patients with advanced head and neck cancer, like the department of ear, nose and throat surgery (ENT), oromaxillofacial surgery (OMF), radiation therapy, hematology/oncology, or palliative medicine, which led to intense demands with regard to interdisciplinary communication and patient tracking. Also in the interdisciplinary setting, the term ‘incurability’ (when patients with head and neck cancer had to be considered ‘incurable’) and other inclusion and exclusion criteria had to be operationalized and consented on.
emotional worries or fear about the upcoming course of disease or death, according to psychiatric comorbidity scores. The provision of more in-depth information about the disease or even palliative care services was rarely demanded. In clinical practice, this complex assessment procedure was feasible, in general, but demonstrated some limitations, as described above. These limitations were related in part to the implications of the disease itself, but also to communication within the interdisciplinary team during multimodal anticancer therapy, and to the difficulties in communicating with a patient who has physical restrictions in his/her communication abilities due to postoperative sequelae or local tumor growth. In most cases, study inclusion also led to palliative care consultation and respective therapy. The multifaceted and severe distress in newly diagnosed patients with incurable head and neck cancer justifies an early integration of palliative care into the oncology setting, as evaluated by Temel et al. [3] for patients with lung cancer or by Zimmermann et al. [2] for those with mixed cancer entities. 1 eligible patient with fungating neck tumor had been missed to include into the study, palliative care services were not included, and it was not discussed what to do in emergency situations. 2 months later she was acutely operated on in an emergency setting due to massive wound bleeding. The carotid artery had to be ligated, and a massive hemispheric ischemic stroke occurred, leading to death 1 week later in the palliative care unit. Early integration of palliative care services and early assessment would have increased the awareness of possible crises and emergencies during the course of the disease [17].
Limitations Discussion This prospective survey, being part of a nationwide assessment project of the German Cancer Society, evaluated the physical symptoms and psychosocial needs of patients suffering from newly diagnosed incurable head and neck cancer, and presents feasibility data of a methodologically complex assessment procedure in a particularly vulnerable patient population. The majority of patients suffered from inoperable relapse or newly diagnosed distant metastases of their disease which was previously treated in curative intention. Even at diagnosis of incurability, before palliative anticancer treatment began, a broad variability of the perceived symptoms and needs were identified. Some physical symptoms like a dry mouth or the inability to eat what was desired were present in almost all patients. Other symptoms like pain were equally distributed in all graduations from no pain to very severe pain. Overall distress, however, was described in 2 distinct clusters, either very distressed or almost not at all distressed. While the majority of patients appeared in good overall performance state, 5 patients were severely compromised (ECOG score 3/4) even during this early course of the disease. Almost half of the patients fully denied
Head and Neck Cancer Patients at Diagnosis of Incurability
Interpretation of study results is limited by the above-described aspects of feasibility. The most complex questionnaires like the SCNS-SF-34 show some conflicting results compared with physical assessment scores (FACT-G), suggesting that the SCNS questionnaire might not have been fully understood by the study participants. To complete this complex assessment, intense face-to-face study support was required; therefore, a bias towards desired answers cannot be excluded (and has to be assumed when taking the described harsh denial of tobacco or alcohol use into account). Further, the limited number of women participating in this study (according to the much higher disease prevalences in men compared to women) prevented a detailed gender-specific analysis. Angiosarcoma and cutaneous SCC histology was included, despite its different biology, therapy, and clinical course, and even ‘head and neck cancer’ as a group of cancer subtypes rather than a single cancer entity may have contributed to the broad variability of symptoms and needs. Finally, the small number of study patients cannot be considered representative of patients suffering from head and neck cancer in general, but rather provides first insights into the highly individual and complex demands of a particularly vulnerable group of patients.
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Conclusions
Compliance with Ethical Standards
This heterogeneous spectrum and striking variability in the reporting of symptoms and needs, from a virtually uncompromised condition to extremely perceived suffering, justifies a routine screening approach in clinical practice, even at the time of diagnosis of incurability. Considering the above-described aspects that impaired the feasibility of this upfront multidimensional assessment strategy investigated in this study, a first screening should focus on easy-to-handle screening tools (e.g., single-item questionnaires [18]) aiming at identifying those patients who might display more complex demands. These demands then need to be further differentiated by a full multidimensional assessment, in direct contact with the patient, as the basis for a highly individualized, early, comprehensive, pro-active, symptom-guided and needs-oriented therapeutic approach, including multiprofessional palliative care services.
Ethical approval: All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Acknowledgement The study conduct was funded by the German Cancer Society (DKG).
Disclosure Statement All authors declare that there are no conflicts of interest.
References 1 Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA: Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the ENABLE III randomized controlled trial. J Clin Oncol 2015; 33: 1438–1445. 2 Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C: Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet 2014; 383: 1721–1730. 3 Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ: Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010; 363: 733–742. 4 Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, Ferrell BR, Loscalzo M, Meier DE, Paice JA, Peppercorn JM, Somerfield M, Stovall E, Von Roenn JH: American Society of Clinical Oncology provisional clinical opinion: The integration of palliative care into standard oncology care. J Clin Oncol 2012;30: 880–887. 5 German Cancer Guideline Program/Leitlinienprogramm Onkologie (German Cancer Society/Deutsche Krebsgesellschaft, German Cancer Aid/Deutsche Krebshilfe, AWMF): Palliativmedizin für Patienten mit einer nicht heilbaren Krebserkrankung, Langversion 1.0, AWMF-Registernummer: 128/001OL. http://leitlinienprogrammonkologie.de/Palliativmedizin.80.0.html, 2015 [accessed 20.12.2015].
192
6 Radbruch L, Nauck F, Ostgathe C, Elsner F, Bausewein C, Fuchs M, Lindena G, Neuwöhner K, Schulenberg D: What are the problems in palliative care? Results from a representative survey. Support Care Cancer 2013; 11: 442–451. 7 Higginson IJ, Hearn J: Multicenter evaluation of cancer pain control by palliative care teams. J Pain Symptom Manage 1997; 14: 29–35. 8 Miller Reilly C, Watkins Bruner D, Mitchell SA, Minasian LM, Basch E, Dueck AC, Cella D, Reeve BB: A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment. Support Care Cancer 2013; 21: 1525–1550. 9 Becker G, Hatami I, Xander C, Dworschak-Flach B, Olschewski M, Momm F, Deibert P, Higginson IJ, Blum HE: Palliative cancer care: an epidemiologic study. J Clin Oncol 2011; 29: 646–650. 10 National Comprehensive Cancer Network (NCCN): NCCN distress management guideline. www.nccn.org, 2005 [accessed 20.12.2015]. 11 Mehnert A, Müller D, Lehmann C, Koch U: Die deutsche Version des NCCN Distress-Thermometers – Empirische Prüfung eines Screening-Instruments zur Erfassung psychosozialer Belastung bei Krebspatienten. Z Psychiatr Psychol Psychother 2006; 54: 213–223. 12 Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J: The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 1993; 11: 570–579.
Oncol Res Treat 2016;39:186–192
13 McGee HM, O’Boyle CA, Hickey A, O’Malley K, Joyce CR: Assessing the quality of life of the individual: the SEIQoL with a healthy and a gastroenterology unit population. Psychol Med 1991; 21: 749–759. 14 Waldron D, O’Boyle CA, Kearney M, Moriarty M, Carney D: Quality-of-life measurement in advanced cancer: assessing the individual. J Clin Oncol 1999; 17: 3603–3611. 15 Löwe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brähler E: A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord 2010; 122: 86–95. 16 Lehmann C, Koch U, Mehnert A: Validation of the German version of the Short-Form Supportive Care Needs Survey Questionnaire (SCNS-SF34-G). Support Care Cancer 2012; 20: 2415–2424. 17 Nauck F, Alt-Epping B: Crises in palliative care – a comprehensive approach. Lancet Oncol 2008; 9: 1086– 1091. 18 Stiel S, Kues K, Krumm N, Radbruch L, Elsner F: Assessment of quality of life in patients receiving palliative care: comparison of measurement tools and single item on subjective well-being. J Pall Med 2011; 14: 599–606.
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