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Scientific reports · 2024

Жалобы на конкретные заболевания у многих пациентов миэломы, проходящих химиотерапию, автотрансплантацию и поддерживающую терапию в Польше: перекрестное исследование.

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Kurek M, Tatara T, Świtalski J, Gujski M, Fronczak A

Аннотация

В силу своего курса множественная миелома может негативно сказаться на функционировании пациентов. Различные методы лечения также связаны с различными представлениями пациентов о состоянии их здоровья. Цель этого исследования состоит в том, чтобы определить характерные для различных заболеваний жалобы пациентов, страдающих миеломой, в ходе отдельных методов лечения, аутологической трансплантации стволовых клеток и поддерживающей терапии. В состав исследовательской группы входили: 246 (больные)98 в группе химиотерапии, из которых 87 в аутологической гематопоиетической группе трансплантации стволовых клеток и 61 в группе поддержки). Исследование было проведено в период с августа 2020 и декабрь 2021 с ЕОРТК QLQ-MY20 Вопросник. Согласно результатам исследования, пациенты, прошедшие курс химиотерапии, имели наибольшую степень симптомов заболеваний и побочные эффекты лечения, а также наименьшую оценку их перспектив на будущее. Пациенты, получившие поддержку, имеют наименьшую степень симптомов заболевания и побочные эффекты лечения, а также оценивают свой образ тела и перспективы на будущее на самом высоком уровне. Женщины оценивают свои будущие перспективы значительно ниже, чем мужчины. С возрастом симптомы заболеваний, испытываемые пациентами, становятся все более серьезными.
Оригинал публикации

Disease-specific complaints among multiple myeloma patients treated with chemotherapy, autotransplantation and supportive therapy in Poland: a cross-sectional study.

Due to its course, multiple myeloma may negatively affect the functioning of patients. Different treatment methods are also associated with patients' varying perception of their health condition. The purpose of this study is to determine the disease-specific complaints among multiple myeloma patients during selected treatment methods-chemotherapy, autologous hematopoietic stem cell transplantation, and supportive therapy. The study group included 246 patients (98 in the chemotherapy group, of which 87 in the autologous hematopoietic stem cell transplantation group and 61 in the supportive therapy group). The study was conducted between August 2020 and December 2021 with the EORTC QLQ-MY20 questionnaire. According to the study results, patients treated with chemotherapy had the highest degree of disease symptom severity and side effects of treatment as well as the lowest assessment of their perspectives for the future. Patients who received supportive treatment had the lowest degree of disease symptom severity and side effects of treatment, and also assessed their body image and future perspectives the highest. Women assessed their future perspectives significantly lower than men. The severity of disease symptoms experienced by patients increases with age.

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Introduction

In the available scientific literature, one can find information on the increasing incidence of multiple myeloma in Poland and in the world 1 , 2 . The reason for this may be the aging of society and increased diagnostic possibilities 3 . Undoubtedly, the increase in the incidence of multiple myeloma in elderly patients, the presence of different comorbidities in seniors and problems resulting from the aging process cause an increased demand for services from nursing staff. Disease symptoms and complications related to treatment additionally negatively affect patients’ quality of life. Certain activities typical of the nursing profession, such as education, prevention and nursing interventions, may significantly impact and improve the patients’ quality of life 4 . The collected study date provide a subjective assessment of patients and define specific problems in selected groups. Thanks to this knowledge, patients’ problems can be solved and their quality of life can be improved. The International Myeloma Foundation Nurse Leadership Board has identified recommendations for the care of patients with multiple myeloma that primarily relate to maintaining overall health, maintaining bone health, mobility and safety, sexual dysfunction, and kidney health 4 . Similar recommendations, combined with the analysis of data obtained from scientific researches, may be helpful in formulating nursing care plans based on scientific evidence. In modern nursing, strong emphasis is placed on the use of EBNP (Evidence Based Nursing Practice), but in reality, some difficulties can be seen in the process of its implementation. Factors causing difficulties in the implementation of EBNP may include lack of knowledge, work overload, and/or reluctance to change 5 . Nevertheless, there is scientific evidence to support the benefits of implementing EBNP 6 .

Taking up the issue of problems resulting from multiple myeloma is important due to the difficulties in caring for patients suffering from multiple myeloma. A closer understanding of subjective feelings may bring benefits for patients and nursing staff. Thanks to this knowledge, it is possible to eliminate or alleviate symptoms and develop new standards of nursing care.

The purpose of this study is to determine the disease-specific complaints among multiple myeloma patients during selected treatment methods—chemotherapy, autologous hematopoietic stem cell transplantation (autoHSCT) and supportive therapy.

Methods

Study population and data collection

The study population consists of individuals with multiple myeloma who, at the time of the study, were treated with either chemotherapy (patients between the 1–4 cycle of treatment), autoHSCT (patients between the 2–7 days after receiving autotransplantation) or supportive therapy (patients after completion of treatment). Information on the patient’s diagnosis (ICD-10 code: C90.0—Multiple myeloma and malignant plasma cell neoplasms) and treatment method was obtained by analyzing medical records. The study was conducted from August 2020 to December 2021 in 4 Polish centers.

Due to the limited possibilities of contact with patients during the outbreak of the COVID-19 pandemic and the resulting restrictions, the study was conducted in a mixed manner. An additional difficulty in collecting data was the rarity of multiple myeloma.

Research tool

The study was conducted using the diagnostic survey method and the EORTC QLQ-MY 20 questionnaire in two versions: paper and electronic. The selected tool is a continuation of the EORTC QLQ-C30 questionnaire (European Organisation for Reserach and Treatment of Cancer Quality of Life Questionnaire Core 30). It contains 20 questions on a 4-point Likert scale, ranging from 31 to 50. The tool consists of 4 scales: disease symptoms (6 items), side effects of treatment (10 items), body image (1 item), future perspective (3 items). The scales were categorized into 2 domains: symptom scales (disease symptoms, side effects of treatment) and functional scales (body image, future perspective). A high score for the symptom scales represents a high level of problems, whereas a high score for the functional scales represents a high level of functioning. Answers were marked on a 4-point Likert scale (not at all, a little, a lot, very much), and the questions covered, for example, issues related to the feeling of pain and well-being. After applying appropriate calculations, the results for each scale range from 0 to 100.

Access to the questionnaire and its key was obtained from the EORTC group after completing an online form.

Statistical analysis

Statistical analysis was performed using the R language in the RStudio environment. The questionnaire data were calculated using appropriate guidelines, obtaining linearized coefficients. The normality of the data was assessed by graphical methods such as histograms and Q-Q plots. Due to significant deviations from the normal distribution, data were presented as medians with quartile ranges. The Kruskal–Wallis test with a post hoc multiple comparison test was used for comparison between groups. Correlation analysis was conducted using Spearman’s coefficient. P values less than 0.05 were considered statistically significant. The significance level was maintained at p = 0.05. The sample size was calculated with the G*Power 3.1.9.7. program with the following settings: alpha 0.05, effect size 0.25, power 0.80. The total sample result was 159, which means that each group should contain a minimum of 53 people.

In order to check the internal consistency of the questionnaire scales, Cronbach’s Alpha coefficient was calculated.

Ethical considerations

The conducted study is in accordance with the Declaration of Helsinki. The study participants received written information about the purpose and method of conducting the study, which they could read in advance. Informed consent was obtained from all subjects involved in the study. All methods were carried out in accordance with relevant guidelines and regulations.

This study was supported and approved by the Medical University of Warsaw. The university’s bioethics committee approved the study procedures (AKBE/271/2019).

Results

Sample

Two hundred forty-six (246) correctly completed questionnaires were collected (39 in electronic version and 207 in paper version). A total of 138 women and 108 men participated in the study. The survey questionnaire was correctly completed by 98 patients (39.8%) treated with chemotherapy (44 men and 54 women, mean age: 70), 87 patients (35.4%) treated with autoHSCT (39 men and 48 women, mean age: 62), 61 patients (24,8%) treated with supportive therapy (25 men and 36 women, mean age: 68). The age of the respondents ranges from 43 to 83 years, with the youngest patient in the autoHSCT group and the oldest patient in the supportive therapy group.

Preliminary analyses

The individual scales of the tool were characterized by accepted Cronbach’s alpha coefficients (Table 1 ). In turn, Table 2 shows the descriptive statistics of the analyzed variables. Raw scores for each scale and final scores were calculated according to the key. Table 1 Reliability analysis of the EORTC QLQ-MY20 questionnaire according to Cronbach’s Alpha index. Scale Number of items Cronbach’s Alpha Disease symptoms 6 0.851 Side effects of treatment 10 0.724 Body image 1 – Future perspective 3 0.829 Table 2 Basic descriptive statistics. Variable N Min Max Me q1 q3 M SD SE Age 246 43 83 66 61 70 66.2 7.8 0.497 Disease symptoms RS 246 1 3.83 2.17 1.83 2.67 2.24 0.597 0.038 Side effects of treatment RS 246 0.9 3.6 2 1.8 2.3 2.05 0.438 0.028 Body image RS 246 1 4 2 2 3 2.15 0.718 0.046 Future perspective RS 246 1 4 2.67 2 3 2.55 0.684 0.044 Disease symptoms 246 0 94.4 38.9 27.8 55.6 41.4 19.9 1.27 Side effects of treatment 246 0 86.7 33.3 26.7 43.3 35.1 14.6 0.93 Body image 246 0 100 66.7 33.3 66.7 61.5 23.9 1.52 Future perspective 246 0 100 44.4 33.3 66.7 48.4 22.8 1.45 N sample size, Min minimum, Max maximum, Me median, q1 quartile 1, q3 quartile 3, M mean, SD standard deviation, SE standard error, RS raw score.

Table 1
Reliability analysis of the EORTC QLQ-MY20 questionnaire according to Cronbach’s Alpha index.

ScaleNumber of itemsCronbach’s Alpha
Disease symptoms60.851
Side effects of treatment100.724
Body image1–
Future perspective30.829

Table 2
Basic descriptive statistics.
N sample size, Min minimum, Max maximum, Me median, q1 quartile 1, q3 quartile 3, M mean, SD standard deviation, SE standard error, RS raw score.

VariableNMinMaxMeq1q3MSDSE
Age246438366617066.27.80.497
Disease symptoms RS24613.832.171.832.672.240.5970.038
Side effects of treatment RS2460.93.621.82.32.050.4380.028
Body image RS246142232.150.7180.046
Future perspective RS246142.67232.550.6840.044
Disease symptoms246094.438.927.855.641.419.91.27
Side effects of treatment246086.733.326.743.335.114.60.93
Body image246010066.733.366.761.523.91.52
Future perspective246010044.433.366.748.422.81.45

Comparative analysis between groups

In the next stage of the analysis, we compared the investigated variables by type of treatment (Table 3 ). We also verified whether patients treated for multiple myeloma with autoHSCT differed from patients treated with chemotherapy and supportive therapy in terms of the severity of symptoms and level of functioning. For this purpose, groups of patients differentiated by treatment method were compared using the Kruskal–Wallis test, with a multiple ad-hoc comparison test. The results of the analysis are presented in Fig. 1 . The analysis showed statistically significant differences between the compared groups in all the considered variables. A review of descriptive statistics allowed us to conclude that patients undergoing supportive therapy had the lowest degree of disease symptom severity and side effects of treatment. They also rated their body image and future perspectives the highest. On the other hand, patients treated with chemotherapy had the highest degree of disease symptom severity and side effects of treatment and the lowest assessment of their prospects for the future and body image. Table 3 Comparison of the variables by type of treatment. Variable Group 1 (chemotherapy) Group 2 (autoHSCT) Group 3 (supportive therapy) p-value Me q1 q3 Me q1 q3 Me q1 q3 Age 70.50 63.25 78.00 62.00 56.50 65.00 69.00 66.00 70.00 < 0.001 Disease symptoms 55.56 44.44 66.67 33.33 22.22 50.00 33.33 22.22 38.89 < 0.001 Side effects of treatment 36.67 30.00 46.67 36.67 26.67 46.67 26.67 20.00 33.33 < 0.001 Body image 66.67 33.33 66.67 66.67 33.33 66.67 66.67 66.67 100.00 < 0.001 Future perspectives 33.33 33.33 55.56 44.44 33.33 66.67 55.56 44.44 77.78 < 0.001 Me median, q1 quartile 1, q3 quartile 3. Fig. 1 Comparison of factors: disease symptoms ( A ), side effects of treatment ( B ), body image ( C ), and future perspective ( D ) by patient group (1—chemotherapy: patients between the 1–4 cycle of treatment, 2—autoHSCT: patients between the 2–7 days after receiving autotransplantation, 3—supportive therapy: patients after completion of treatment). *p < 0,05, **p < 0,01, ***p < 0,001,****p < 0,0001, ns statistically insignificant result.

Table 3
Comparison of the variables by type of treatment.
Me median, q1 quartile 1, q3 quartile 3.

VariableGroup 1 (chemotherapy)Group 2 (autoHSCT)Group 3 (supportive therapy)p-value
Meq1q3Meq1q3Meq1q3
Age70.5063.2578.0062.0056.5065.0069.0066.0070.00< 0.001
Disease symptoms55.5644.4466.6733.3322.2250.0033.3322.2238.89< 0.001
Side effects of treatment36.6730.0046.6736.6726.6746.6726.6720.0033.33< 0.001
Body image66.6733.3366.6766.6733.3366.6766.6766.67100.00< 0.001
Future perspectives33.3333.3355.5644.4433.3366.6755.5644.4477.78< 0.001
Fig. 1 Comparison of factors: disease symptoms ( A ), side effects of treatment ( B ), body image ( C ), and future perspective ( D ) by patient group (1—chemotherapy: patients be…
Fig. 1 Comparison of factors: disease symptoms ( A ), side effects of treatment ( B ), body image ( C ), and future perspective ( D ) by patient group (1—chemotherapy: patients between the 1–4 cycle of treatment, 2—autoHSCT: patients between the 2–7 days after receiving autotransplantation, 3—supportive therapy: patients after completion of treatment). *p < 0,05, **p < 0,01, ***p < 0,001,****p < 0,0001, ns statistically insignificant result.

The analysis further examined whether there was a relationship between the investigated variables and age, both in general and in individual groups. For this purpose, Pearson’s correlation analysis was performed. The investigated variables were also compared by gender using the Mann Whitney test. The results are shown in Table 4 . Table 4 Correlation between age and parameters without grouping patients. Var1 Var2 Without grouping Group 1 (chemotherapy) Group 2 (autoHSCT) Group 3 (supportive therapy) Cor p-value Cor p-value Cor p-value Cor p-value Age Disease symptoms 0.33 0.00 0.38 0.00 − 0.09 0.39 0.29 0.02 Side effects 0.00 0.97 0.05 0.63 0.03 0.82 0.14 0.30 Body image 0.14 0.03 0.08 0.43 − 0.02 0.83 − 0.06 0.68 Future perspective − 0.05 0.46 − 0.02 0.86 − 0.07 0.52 − 0.05 0.72 Var1 variable 1, Var 2 variable 2, Cor Spearman correlation.

Table 4
Correlation between age and parameters without grouping patients.
Var1 variable 1, Var 2 variable 2, Cor Spearman correlation.

Var1Var2Without groupingGroup 1 (chemotherapy)Group 2 (autoHSCT)Group 3 (supportive therapy)
Corp-valueCorp-valueCorp-valueCorp-value
AgeDisease symptoms0.330.000.380.00− 0.090.390.290.02
Side effects0.000.970.050.630.030.820.140.30
Body image0.140.030.080.43− 0.020.83− 0.060.68
Future perspective− 0.050.46− 0.020.86− 0.070.52− 0.050.72

It is worth noting that there is a correlation between the age of patients and the severity of disease symptoms, especially in the group of patients treated with chemotherapy and supportive therapy. This means that as the age of the respondents increased, the degree of severity of disease symptoms also increased. In the case of other variables, no statistically significant relationships were noted.

Gender differences were also verified in terms of the severity of symptoms and level of functioning. For this purpose, women and men were compared across the investigated variables with the Mann–Whitney test. The results of the analysis are presented in Table 5 . The analysis showed a statistically significant difference between women and men only in the range of the assessment of future perspectives. It turned out that women assessed their future perspectives significantly lower than men. Table 5 Comparison of variables by gender. Variable Men Women p-value Me q1 q3 Me q1 q3 Age 65.50 61.00 69.00 67.00 61.00 71.00 0.19 Disease symptoms 33.33 27.78 50.00 44.44 27.78 55.56 0.13 Side effects 33.33 23.33 43.33 33.33 26.67 46.67 0.17 Body image 66.67 66.67 66.67 66.67 33.33 66.67 0.12 Future perspectives 55.56 33.33 66.67 44.44 33.33 66.67 0.01 Me median, q1 quartile 1, q3 quartile 3.

Table 5
Comparison of variables by gender.
Me median, q1 quartile 1, q3 quartile 3.

VariableMenWomenp-value
Meq1q3Meq1q3
Age65.5061.0069.0067.0061.0071.000.19
Disease symptoms33.3327.7850.0044.4427.7855.560.13
Side effects33.3323.3343.3333.3326.6746.670.17
Body image66.6766.6766.6766.6733.3366.670.12
Future perspectives55.5633.3366.6744.4433.3366.670.01

Discussion

Nursing based on the use of models defined by well-known nursing theorists, individualization of care, and holism contribute to improving patients’ quality of life 7 . The available literature indicates that the concept of quality of life is considered in the care of patients with multiple myeloma, and understanding this term and determining what is important for the patient is part of a holistic approach.

Many tools exist to determine the level of quality of life, but they are rarely used in practice. The Kirkpatrick 2023 study conducted in 26 centers in England and Wales shows that only 3 centers collect data on quality of life as part of standard care 8 . Clinical nurse specialists analyze the results and prepare care plans based on the obtained data 8 . The British Boland 2014 study, aimed to holistically assess the needs of patients treated for advanced myeloma using the multidimensional SPARC (Sheffield Profile for Assessment and Referral for Care) tool, indicates its usefulness in providing supportive and palliative care for multiple myeloma patients. The results of said study determine the symptoms that bother patients. Said symptoms include quite severe fatigue, drowsiness and insomnia during the day, pain, sexual life difficulties, concern about the treatment side effects and the impact of the disease on family and friends. It is recommended that patients with multiple myeloma be assessed for unmet needs 9 . Referring to Virginia Henderson’s nursing theory, which focuses on the health needs of people during everyday life activities, a nurse should provide the help that a person needs at the moment. Therefore, the care plan needs to be adapted and modified depending on the patient’s situation. A person’s needs can change even in a short period of time 7 . Referring to the issues discussed in the article, each group of patients will require a different approach.

The analysis of the study results revealed that patients treated with chemotherapy exhibited the highest degree of disease symptom severity and side treatment effects. The Zeng 2023 study conducted among 177 patients in China with multiple myeloma treated with chemotherapy shows that 97.65% of patients suffer from multiple symptoms, mainly pain, which affects quality of life the most, as well as mental and gastrointestinal symptoms that negatively affect health-related quality of life. The authors of the study recommend that pain relief be given priority in this group of patients, as relieving one symptom can alleviate others simultaneously. While preparing a care plan and implementing interventions, nurses should consider correlations between symptoms and focus on the whole, not just a single problem 10 . The authors of the LeBlanc 2022 study conducted among 690 patients with multiple myeloma in the United States conclude that patients with multiple myeloma have a significantly worse quality of life than the general population. Physical health, mental health and physical functioning are significantly lower than the average for the general population. The authors suggest that further research is needed to describe the relationship between treatment regimens and quality of life 11 . The study shows the lowest level of quality of life among patients treated with chemotherapy, and the highest among patients treated with supportive therapy.

Undoubtedly, patients’ mental health can influence their quality of life. The study shows that women and patients treated with chemotherapy asses their future perspectives at the lowest levels among the studied groups. The Fischer 2022 study of 70 patients with multiple myeloma in Germany reported that overall health status scores were higher in patients with less severe anxiety/depression. Quality of life was significantly reduced after the initiation of chemotherapy in terms of body perception, side effects of treatment, and cognitive functioning. Additionally, increased levels of anxiety and depression, female gender, older age, decreased functional status and recurrent illnesses may be early indicators of reduced levels of quality of life 12 . The Papathansiou 2020 study of 87 patients with hematologic malignancies in Greece indicates that higher levels of psychological stress and overall poor mental health are associated with a poorer quality of life. Patients also exhibit problems with memory and attention, increased levels of anxiety and depression, and decreased sexual activity, which are also associated with an acquired negative body image. High levels of anxiety and stress may indicate unmet needs of patients 13 . The results of the Cho Yoo-Rin 2020 study conducted among 141 patients in Korea identified anxiety and depression as factors influencing the supportive care needs of patients with multiple myeloma. The authors of the study demonstrated that the needs for supportive care in patients are related to their emotional state, and the needs of patients should be individually determined and taken into account to reduce anxiety and depression 14 .

The study results indicate that disease symptoms are more severe among older patients. The treatment outcomes for elderly patients battling multiple myeloma are often worse due to the presence of comorbidities and increased susceptibility to side effects of treatment 15 . As the body ages, certain physiological functions and activities of daily living may become weaker. A proper approach is incredibly important for this group of patients due to their vulnerabilities. Identifying vulnerable patients is important in adjusting the care plan to meet their needs. The George 2021 review article indicates that advanced age (75 years and older) increases the risk of complications in patients. Advanced age and low BMI (Body Mass Index) increase the risk of broken bones. Patients with multiple myeloma have a higher incidence of falls compared to the control group, but physical exercise may reduce it. Most elderly patients suffer from anemia, which may result in impaired physical activity, depression, and increased mortality. Due to the frequent occurrence of venous thromboembolism in patients with multiple myeloma and due to other comorbidities, the elderly suffer from the consequences of anticoagulant effects, which can be quite a challenge. Deterioration of vision, muscle weakness, and impaired grasping functions may cause difficulties in administering drugs via subcutaneous injections. Simultaneously, the use of anticoagulants and the high risk of falls also result in a high risk of bleeding 16 .

Thanks to their specialized knowledge and experience in patient education, oncology, hematology and other nurses caring for patients with multiple myeloma play an important role in patient care, contributing to an improved quality of life. As new information on hematology treatment and care becomes available, nurses must be aware of factors that optimize outcomes to help patients achieve the best possible psychophysical well-being.

The limitations of the study are mainly a small sample and unequal size of individual groups. Because of the COVID-19 pandemic, some hospitals refused the agreement to conduct the study. Patient’s often didn’t agree to participate in the study due to poor health status. The fact that multiple myeloma is a rare disease, influence on the groups size.

Conclusions

The severity of problems affecting patients with multiple myeloma varies depending on the treatment method. Patients treated with chemotherapy had the highest degree severity of disease symptoms and side effects of treatment and the lowest assessment of their perspectives for the future and body image. Patients treated with supportive treatment had the lowest degree of disease symptom severity and treatment side effects, and also rated their body image and future perspectives the highest. Women assessed their future perspectives significantly lower than men. This group of patients may require extra psychological support. The severity of the disease symptoms experienced by patients increases with age, especially in the chemotherapy and supportive therapy groups. This may indicate difficulties in everyday functioning and an increased need for nursing care.

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Author contributions

Conceptualization: M.K., T.T. and A.F.; Methodology: M.K., T.T. and A.F.; Formal Analysis: J.Ś. and M.G.; Writing–Original Draft Preparation: M.K., T.T., J.Ś., M.G. and A.F.; Writing–Review & Editing: M.K., T.T., J.Ś., M.G. and A.F.; Supervision: M.G. and A.F. All authors have read and agreed to the published version of the manuscript.

Data availability

The datasets generated during and/or analyzed during the present study are available from the corresponding author upon a reasonable request.

Competing interests

The authors declare no competing interests.

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ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты