A Clinical View on the Palliative Care Challenges for Oncology Patients

doi:10.21203/rs.3.rs-3933338/v1

Objectives. To improve the organization and delivery of palliative care for cancer patients based on the work analysis of the Cancer Center for the period from 2018 to 2023.

Methods. From 2018 to 2023, 69,110 patients were grouped as follows: 1st – 36,443 patients of II-III stage, II clinical group, which received complex drug treatment according to the protocol and recommendations of the NCCN (according to nosologies); 2nd - 24,296 patients of IV stage, II clinical group, who received only drug treatment according to these recommendations and the clinical protocol; 3rd – 8,371 patients in IV stage, IV clinical group that received palliative care. Group 3 was further divided into subgroups: a) 3,022 patients who received inpatient palliative care (hospice); b) 5349 patients who received outpatient care.

Results. Over the past two years, there has been a significant increase (p < 0.05) in the number of patients in all groups. In the structure of the second group, the preference of patients with localization of the mammary gland and organs of the abdominal cavity was determined - 14,938 patients (61.48%). The correlation of the contingent of patients who received palliative drug treatment with those who received palliative care was determined.

Conclusion. It is possible to foresee patients receiving inpatient or mobile palliative care. Since there is a clinical course during hospitalization for palliative care, it is possible to foresee a certain set of measures taking into account a specific nosology.

palliative medical treatment

palliative care

hospice

palliative mobile care

palliative care organizations

According to the International Agency for Research on Cancer GLOBOCAN 2020, there were 19.3 million new cancer cases worldwide in 2020 (18.1 million excluding non-melanoma skin cancer) and almost 10.0 million cancer-related deaths (9.9 million, excluding non-melanoma skin cancer). In 2040, the global burden of cancer is expected to be 28.4 million cases, a 47% increase over 2020, with a greater extension in transition economies (64% to 95%) compared to developed economies (32% to 56%). Europe accounts for 22.8% of all cancer cases and 19.6% of cancer-related deaths, although it has 9.7% of the world's population.

The International Agency for Research on Cancer also provides the incidence rate of morbidity in Ukraine for the 2020 year.

Figure 1 presents the morbidity, which in 2020 reached 162594 cases, the map shows the incidence rate of Ukraine, which according to the global standard was 212.8 cases per 100,000 population. Among the countries worldwide, Ukraine ranks second highest out of five groups of countries in terms of morbidity.

Figure 2 presents the mortality rate in Ukraine from malignant diseases in 2020, amounting to 84194 deaths based on the global standard, which corresponds to 102.5 cases per 100,000 population and has a high negative global rating and is included in the second group of 5 groups of countries [1].

Cancer is the first or second leading cause of death under the age of 70 in 112 out of 183 countries and is the third or fourth leading cause of death in another 23 countries (Figure 3).

According to the presented data, Ukraine belongs to the first subgroup of countries in the world with a high mortality rate from cancer, ranking as the second leading cause of death after cardiovascular diseases [2].

In Ukraine, 1,105,152 individuals were registered for malignant diseases in 2022, with 109604 of these cases recorded in Kyiv. The rate of neglect of malignant diseases in Ukraine in 2022 was 22.4% and increased by 1.4% compared to 2021. These are patients who have been diagnosed with the IV stage of the disease, which makes it impossible to conduct comprehensive specialized treatment, and maintained with sub- or decompensated concomitant pathology with a severe general condition [3].

The presented data testify to the increase in the cancer incidence rate and mortality in Ukraine, a high level of neglect of cancer diseases against the background of population aging, the prevalence of the main risk factors associated with socio-economic development, contamination of territories by military aggression, and distress syndrome in cancer patients, which requires the development of effective screening programs, early diagnosis of malignant diseases, national medical and social palliative care programs.

Aim. To improve the organization and delivery of palliative care for cancer patients based on the work analysis of the Cancer Center for the period from 2018 to 2023.

A retrospective study of the Cancer Center was performed using specialized medical treatment, palliative treatment, and palliative care (inpatient - hospice; outpatient - mobile palliative care) from 2018 to 2023 (Figure 4).

Based on the data of registered outpatient charts and medical history, the following groups of patients were identified: 1^st group – 36443 patients with malignant disease II-III stage, II clinical group, who underwent complex therapy with medical treatment according to the NCCN guidelines and recommendations (by nosology); 2^nd group – 24296 patients with IV stage of malignant disease, II clinical group, who underwent only medical treatment according to the NCCN guidelines and recommendations (by nosology); 3^rd group – 8371 patients with IV stage, IV clinical group, who were divided into subgroups: a) 3022 patients who received inpatient palliative care (hospice); b) 5349 patients who received outpatient care by mobile palliative care teams.

The inclusion criteria were: malignant disease II-III stage, II clinical group with complex therapy; malignant disease IV stage, II clinical group that received medical treatment; diseases of the IV stage, IV clinical groups. The exclusion criteria: age of the patient up to 18 years; patients with stage I-III of a malignant disease with concomitant pathology that required palliative care; incomplete information about the patient.

Statistical analysis was conducted by Statistical software EZR v. 1.54 (graphical user interface for R statistical software version 4.0.3, R Foundation for Statistical Computing, Vienna, Austria) [4]. Quantitative results were described with a mean ± standard deviation (in the case of a normal distribution) or median value and interquartile range (in the case of a non-normal distribution) and were compared using analysis of variance or the Kruskal-Wallis test, respectively. Factors with a value of p < 0.05 were considered statistically significant.

Based on the inclusion and exclusion criteria, 69110 patients who received medical treatment during the specified period were selected for assessment. Following an analysis of the dynamics in the number of patients receiving medical care, and in the absence of structural changes in the institution during the specified period, the upcoming indicators were obtained (Table 1).

Table 1. Content of special treatment and palliative care for oncology patients for the period from 2018 to 2023

Type of medical treatment	2018	2019	2020	2021	2022	2023
Chemotherapy treatment	4790	5224	5447	5907	6680*	8435*
Palliative chemotherapy	3447	3705	4010	4030	4088	5016*
Inpatient palliative care	551	577	472	506	499	517
Outpatient palliative care	883	998	706	770	789	1203*

Note: * - p < 0.05 compared to the 2018 figure

The data presented in Table 1 indicate the quantitative growth of patients during the research period in all groups except inpatient palliative care. Taking into account that the inpatient palliative department has a permanent bed fund (25 beds), therefore, despite the growing need, it is not possible to objectively increase this indicator. The number of palliative patients who received mobile palliative care increased statistically significantly (p < 0.05) in 2023. According to the presented data, the number of patients who received chemotherapy treatment has been increasing from 2020 until 2023 and has a statistically significant difference (p < 0.05) compared with 2018. During the treatment period of 36443 patients who underwent complex therapy, which included medical treatment according to NCCN guidelines and recommendations (by nosology), 153514 episodes of hospitalization were registered in the system of the National Health Service of Ukraine (NHSU).

Among the provided findings, notable is the statistical increase (p < 0.05) in 2023 in the number of patients in the IV stage, II clinical group that received medical treatment following NCCN guidelines and recommendations (by nosology). The dynamics of the results, for visual perception, are presented in Figure 5.

The second group of patients, undergone palliative chemotherapy treatment, demonstrates a substantial prognostic significance in predicting the emergence of requirements for exclusively palliative care. Based on the localization of the malignant process the distribution according to absolute data is outlined in Table 2.

Table 2. Nosological groups that received palliative chemotherapy at the Kyiv City Clinical Oncology Center in the period from 2018 to 2023 year (except children)

Groups of malignant diseases (by localization)	2018	2019	2020	2021	2022	2023
Head and neck	130	135	133	142	154	204
Lungs	374	410	390	340	414	477
Breast	1027	1249	1334	1357	1686*	1902*
Abdominal organs (stomach, colon, pancreas, liver)	951	1057	1066	1036	1041	1232*
Female reproductive system (ovary, uterus, cervix)	443	484	441	426	401	576
Urinary system (kidney, adrenal gland, ureter, bladder, prostate)	514	681	605	362	351	634
Oncohematological	8	14	41	42	41	91*

Note: * - p < 0.05 compared to the 2018 figure

In the structure, the leading position is held by the nosological group of patients with malignant diseases of the breast and abdominal organs - 14938 patients (61.48%). Over the past two years, the number of patients who received chemotherapeutic treatment increased statistically significantly (p < 0.05). Simultaneously, an increase was noted in all observation groups. Figure 6 illustrates the structure of patients with IV stage II clinical group for the last two years (2022-2023).

The defined group of patients who received palliative treatment is important as a prognostic factor in the further delivery of palliative care. After analyzing by year, a direct correlation of the mentioned data was identified with the structure of patients who received inpatient palliative care. With the current understanding of the structure of patients receiving palliative treatment, it is possible to predict for the upcoming year the main group of patients receiving only palliative care. Table 3.

Table 3. Prediction of the main palliative care patient groups based on the structure of receiving palliative treatment

Malignancy (by localization and nosology)	Ranking place in the structure	% - correlation
Abdominal organs (stomach, colon, pancreas, liver)	І	20,1
Breast	ІІ - ІІІ	13,1
Lungs	ІІІ - ІІ	12,66
Urinary system (kidney, adrenal gland, ureter, bladder, prostate)	IV – V	6,1

The results of the third research group indicate a statistically significant (p < 0.05) increase in the number of patients who received mobile palliative care, which is especially important during the COVID-19 quarantine and martial law. In 2022-2023, 8738 episodes of mobile palliative care were registered in the National Health Service (1 episode – 4 specialist visits and the remaining telecommunication interactions). In the department of inpatient palliative care, 47 symptomatic surgical interventions were performed during the research period, and 109 surgical procedures were performed: 19 - percutaneous cystostomies; 39 - laparocentesis; 34 - thoracentesis, and 17 - tracheostomies.

The World Health Organization defines palliative care as an approach to improving the quality of life of individuals and their families who are faced with a problem related to a life-threatening illness and require a unified strategy for end-of-life care that integrates all relevant services and organizations. Quality standards (QS13) developed by the National Institute for Health and Care Excellence (NICE), require coordinated action between responsible agencies [5].

Choosing palliative care is not a surrender of hope or hastening death; instead, it represents a decision to receive the most expert and high-quality care during the final stage of life. Symptomatic treatment and care aim to provide relief of pain and other disturbing symptoms, and integration of psychological, social, and spiritual aspects of the patient to support as active a life as possible until death [6].

In the process of providing palliative care in Ukraine, we use the Order of the Ministry of Health of Ukraine №1308 dated June 4, 2020. [7]. Which was presented in a very timely and efficient manner during the period of coronavirus restrictions, the WHO European Bureau together with the European Association of Palliative Care in 2019 year surveyed 21 countries in Eastern Europe, including Ukraine, and it was found that a third of the countries still do not have postgraduate training in palliative care. WHO undertook to create a core curriculum that is based on multidisciplinarity, the importance of interprofessional learning in courses, and practices for collaboration in palliative care teams [8, 9].

In the preamble of the currently effective Order of the Ministry of Health of Ukraine, a training policy was established with the definition of specific tasks. A multidisciplinary team principle was formed, and educational and professional tasks were set not only for specialists in palliative medicine but for all interested parties. Important attention is paid to primary care physicians (general practitioners, therapists), who are an indispensable component of a multidisciplinary team in the treatment of a patient. However certain aspects of the law require consensus, and there is a necessity to formulate an additional appendix "Criteria (legal, professional) for hospitalization and discharge of a patient from an inpatient palliative care unit." At the moment, clinicians have no legal clarifications regarding the settlement of the issue of resuscitation measures for an incurable patient. The crucial matter of hemotransfusion for an incurable patient, along with other related issues, also needs to be resolved.

Despite the growing demand for palliative care programs indicated by the aforementioned data, the number of such programs has not increased sufficiently to meet the demand. Consequently, there is an urgent requirement for periodic reviews of legislative acts, a need underscored by the annual updates to the NCCN Palliative Care international guidelines V2.2023[10]. In which an assessment of the benefits and burdens of palliative polychemotherapy is presented and recommendations are made that deserve consideration, specifically: "many symptoms of malignancy can be alleviated by controlling the cancer with anticancer therapy and for each individual based on the specific disease present"; "Patients and families must be informed that palliative care is an integral part of comprehensive cancer treatment"; "Patients should be empowered to understand the expected trajectory of their terminal illness."

The research conducted by the authors: Weeks JC, et al. [11] revealed that individuals who overestimated their survival were more prone to experience a challenging or difficult death; Smith TJ, et al. [12] found that the majority of patients express a preference for receiving honest information, even when it involves bad news. The NCCN.2023[10] guidelines provide indicators of deterioration in the patient prognosis, this information is crucial for swiftly determining appropriate strategies for palliative care specialists and primary care doctors (physicians and general practitioners). Especially: reduced performance (ECOG score ≥3; KPS score ≤50), persistent hypercalcemia, metastases to the central nervous system, delirium, MBO, superior vena cava (SVC) syndrome, spinal cord compression, cachexia, malignant effusions, need for palliative stenting or gastrostomies, other serious concomitant diseases. Many patients diagnosed with stage IV cancer, particularly metastatic lung cancer, pancreatic cancer, and multifocal glioblastoma, would benefit from receiving palliative care at the time of diagnosis, as survival expectancy is limited.

Returning to the discussion of the obtained results regarding the provision of specialized medical treatment, palliative treatment, and palliative care, a warning sign is observed, namely: the number of patients of II-III stage, II clinical group (n = 36443) almost corresponds to the number of patients of IV stage, II clinical group (n = 24296) + IV stage, IV clinical group (n = 8371). The data indicate challenges in the early diagnosis of malignant diseases, the mitigation may be that the results were obtained at the institution where an inpatient palliative care unit (hospice) is deployed, so the outcomes in the city of Kyiv may differ.

The dynamics of palliative care results showed a statistically significant increase in the number of patients who underwent chemotherapy and palliative treatment during the research period. The growth has been observed since 2020, and we attribute it to the enhancement of patient's access to quality and free medicines under the State program "Affordable Medicines". The increase in the provision of palliative treatment for Kyiv residents is substantiated by the purchase of targeted and immunotherapeutic drugs with the budget funds of the Kyiv City Council, which makes it possible to personalize treatment for this category of patients. The rise of patients served by mobile palliative care teams is especially important during the period of COVID-19 quarantine and martial law. From 2022 to 2023, 8738 episodes were registered in the NHSU (1 episode – 4 visits by specialists and the remaining telecommunication interactions; and at least 11 calendar days), which indicates the intensity of multidisciplinary teamwork and the important role of the general practitioners in this process.

Following a structural analysis of patients who received palliative treatment and conducting an analogy with the data on the provision of palliative care, we concluded that it is possible to predict the group of patients for inpatient palliative care. This prediction is important as, for each medical condition, there exists a defined clinical course of the disease. When transitioning to palliative care, there arises a necessity to implement a specific set of measures tailored to the particular nosology.

Performance indicators of oncology inpatient palliative care highlight the need to involve surgical specialists to provide palliative care. Thus, during the research period, 47 symptomatic surgery operations, and 109 surgical procedures (percutaneous cystostomy, laparocentesis, thoracentesis) were performed.

Therefore, to ensure the provision of high-quality inpatient palliative care, optimize public funds and transportation, and allocate staff resources to additional organizational matters, the palliative oncology department needs to be located as a structural unit within an oncology institution (such as an institute, center or dispensary) and financed by the NHSU according to special criteria for delivering palliative care to oncology patients.

The team of authors reached a consensus that when a cancer patient receives an adequate level of palliative care per clinical guidelines, there is a decrease in the need and quantity of palliative care. Conversely, when opportunities are missed, leading to a reduction in palliative treatment, the demand for palliative care tends to increase.

1. Regulatory and legal support: considering the escalating incidence of oncological cases within the population of Ukraine, the dynamic migration processes due to the state of war, and the emigration of predominantly young individuals and women, there arose a necessity to review and amend the regulatory and legal acts governing the provision of palliative care for incurable cancer patients.

Required:

- to create an initiative multidisciplinary group dedicated to the development and preparation of the aforementioned acts, which must necessarily involve clinicians who directly work with patients, guardians, and family members;

- the needs of the palliative patient should be realistically assessed, without violating human dignity, according to specialties and taking into account the economic capabilities of the state;

- to obtain legal clarifications regarding the issue settlement of resuscitation measures and hemotransfusion to an incurable patient;

- to establish a centralized territorial (rather than scattered) psychological support service for the patient, guardian, family members, especially minor children living with the patient;

- to develop and implement a program of psychological, rehabilitation, and material support for employees who provide palliative care (spanning from primary care to hospice services).

2. To enhance the quality of palliative care, and organizational and financial support, allocate inpatient palliative care by categories according to the scope of its provision. Oncological palliative care should be classified as providing a comprehensive set of palliative measures for performing symptomatic surgical operations and procedures and having appropriate support.

3. The oncological palliative service should operate as a unit of a multidisciplinary cancer clinic, enabling the provision of qualified assistance and ensuring controlled expenditure of state funds.

4. Develop educational programs for training the patient, guardian, and family members in practical skills of delivering palliative care to an oncological patient in a palliative hospital setting.

Conflict of interest

Authors report no conflict of interest.

Financial disclosure

None declared.

Data sharing statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Ethics approval and consent to participate

The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Medical Ethics Committee of the National University of Health Care of Ukraine (protocol No. 11 dated 05.02.2023). All patients or their relatives provided written informed consent.

Consent for publication

Not Applicable

Authors' contributions

Substantial contributions to the conception ( All authors)

Design of the work (Gordiichuk P., Gordiichuk. M.)

The acquisition, analysis (Kalachov O., Konysheva A., Kondratenko A.)

Interpretation of data (Gordiichuk P., Moiseenko R., Kondratenko A.)

The creation of new software used in the work (Konysheva A., Pogorelov O.)

Have drafted the work or substantively revised it ( All authors)

Approved the submitted version ( All authors)

All authors reviewed the manuscript.

Hyuna Sung, Jacques Ferlay, Rebecca L Siegel et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. https://doi.org: 10.3322/caac.21660
World Health Organization (WHO). Global Health Estimates 2020: Deaths by Cause, Age, Sex, by Country and by Region, 2000-2019. WHO; 2020. Accessed December 11, 2020. who.int/data/gho/data/themes/mortality-and-global-health-estimates/ghe-leading-causes-of-death
Рак в Україні, 2021-2022. Захворюваність, смертність, показники діяльності онкологічної служби. //Бюлетень національного канцер-реєстру України, № 24. – Київ: - 2023; - 143 с. http://www.ncru.inf.ua/publications/BULL_24/PDF/13-23-vstup.pdf
Kanda Y. Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant. 2013;48:452–458.
End of life care for adults: service delivery. NICE guideline [NG142]Published: 16 October 2019; https://www.nice.org.uk/guidance/ng142
American Academy of Hospice and Palliative Medicine. Strategic Plan 2020–2024. Approved by the AAHPM Board of Directors. 2020; https://aahpm.org
Наказ Міністерства охорони здоров'я України від 04.06.2020 № 1308 " Про удосконалення організації надання паліативної допомоги в Україні", зареєстрований у Міністерстві юстиції України 01 липня 2020 р. за № 609/34892. https://zakon.rada.gov.ua/laws/show/z0609-20#Text
Stähli1 A., Stiel S., Paal P., Lorenzl S., Elsner F. Postgraduate palliative care education and curricular issues in Central Asia, Eastern and South-Eastern Europe: Results from a quantitative study. Palliat Med Pract 2020;14(2):81-88. https://doi.org:10.5603/PMPI.2020.0008
Leppert W. Palliative and supportive care: progress needed in clinical care, research and education. Palliat Med Pract 2023;17(3):125-127. https://doi.org:10.5603/pmp.97571
NCCN Clinical Practice Guidelines in Oncology. Palliative Care. NCCN Guidelines®. Version 2.2023 — April 24, 2023 https://www.nccn.org/professionals/physician_gls/pdf/palliative.pdf
Weeks JC, Cook EF, O'Day SJ, et al. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA 1998;279:1709-1714. http://www.ncbi.nlm.nih.gov/pubmed/9624023.
Smith TJ, Dow LA, Virago EA, et al. A pilot trial of decision aids to give truthful prognostic and treatment information to chemotherapy patients with advanced cancer. J Support Oncol 2011;9:79-86. http://www.ncbi.nlm.nih.gov/pubmed/21542415.

No competing interests reported.

A Clinical View on the Palliative Care Challenges for Oncology Patients

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Abstract

Figures

Introduction

Materials and methods

Results

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

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