Quality of Life Among Polish Patients with Multiple Myeloma: A Cross-Sectional Study

Introduction

Plasma cell myeloma, also known as multiple myeloma, is the most common malignancy among plasma cell tumors [1,2]. The incidence of multiple myeloma is higher in Black individuals than in White individuals [1,2].

According to the data of the Global Cancer Observatory, in 2022, there were 187774 new cases of multiple myeloma worldwide (accounting for 0.9% of all cancer diagnoses), of which there were 103 767 affected men (age-standardized incidence of 2.1 per 100 000) and 84 007 women (age-standardized incidence of 1.5 per 100 000) [3]. In 2022, there were 121 252 multiple myeloma-related deaths (accounting for 1.2% of all cancer diagnoses), with 66 938 in men (age-standardized mortality of 1.3 per 100 000) and 54 314 in women (age-standardized mortality of 0.9 per 100 000) globally [3]. In Poland in 2022, there were 2433 new cases of multiple myeloma, with 1145 in men (age-standardized incidence of 3.1 per 100 000) and 1288 in women (age-standardized incidence of 2.5 per 100 000) [4]. During this time, there were 1787 multiple myeloma-related deaths in Poland, with 867 in men (age-standardized incidence of 2.2 per 100 000) and 920 in women (age-standardized incidence of 1.6 per 100 000) [4].

Multiple myeloma is characterized by excessive and abnormal proliferation of plasma cells. Pathological plasma cells produce large amounts of specific immunoglobulin, which are detected in the blood serum or urine. Important features of myeloma include bone osteolysis and frequent fractures, infections, bone pain, kidney problems, fatigue, weakness, and anemia [5].

The standard first-line treatment for all patients with newly diagnosed multiple myeloma is combination therapy consisting of a proteasome inhibitor (bortezomib), an oral immunomodulatory agent (lenalidomide), and dexamethasone, known together as the VRD regimen, which is administered in approximately 3 to 4 cycles [6–8]. This induction therapy combined with autologous hematopoietic stem cell transplantation (autoHSCT) and subsequent supportive treatment with lenalidomide is the standard of care for the group of patients qualified for the autotransplantation procedure [6–8]. In the group of high-risk patients, defined by the presence of genetic mutation, daratumumab, bortezomib, lenalidomide, and dexamethasone (the Dara-VRD regimen) are used alternatively, and supportive treatment is based on bortezomib in combination with lenalidomide [6–8]. Patients who are not eligible for autoHSCT, typically those over 70 years of age, are treated with bortezomib, lenalidomide, and dexamethasone for approximately 8 to 12 cycles [6–8]. Supportive treatment in this group of patients is standard, or alternatively, daratumumab, lenalidomide, and dexamethasone (DRD regimen) are used until progression [6–8].

Genetic mutations are considered a major prognostic factor in patients with multiple myeloma. The presence of several mutations worsens patient prognosis, which mainly means a shorter progression-free survival and overall survival time [9].

Multiple myeloma is a serious health concern for patients, significantly affecting their quality of life. The therapeutic process is often challenging to endure. Disease-related symptoms and treatment adverse effects significantly interfere with patients’ ability to maintain daily life routines [10]. In health sciences, there is currently an increased interest in the topic of quality of life and in using a holistic approach with patients. One of the challenges of modern nursing is improving patient quality of life. Numerous scientific studies on the quality of life in cancer patients have demonstrated that their quality of life is significantly reduced, with symptoms related to both the disease and its treatment adversely affecting physical and mental well-being [5,10].

Patients with multiple myeloma have a lower quality of life than both the general population [11] and patients with other hematologic malignancies [5]. The main factors contributing to the deterioration of quality of life include disease-related symptoms and adverse effects of treatment [11,12]. Additional contributing factors are low mood, depression, and fatigue, which are classified as psychological factors [12]. Furthermore, 1 study from the United Kingdom indicates that patients with relapse or disease progression have a worse quality of life than do patients in a stable phase of the disease [13]. The present study addresses the issue of quality of life in Polish patients with multiple myeloma and aims to contribute to a closer understanding of the challenges they face, in order to inform strategies for improving their quality of life. In view of today’s clinical challenges and the limitations in the medical literature, care of and attention to the quality of life of patients with multiple myeloma are of significant importance. Issues such as the impact of treatment adverse effects on daily functioning, the need to improve patient care strategies, and the organization of psychological support require particular attention from the healthcare personnel responsible for patient care.

This study is part of a broader scientific project. In our search, we found no similar studies in the available medical literature comparing the quality of life of patients treated with chemotherapy, autoHSCT, and supportive therapy. Understanding the quality of life of patients will enable nursing staff to better recognize and respond to patients’ needs. Developing a care plan based on the knowledge obtained through this study can facilitate the work of the staff, while addressing the patients’ issues. So far, we have published 2 papers regarding patients with multiple myeloma. In the first paper, we described disease-specific concerns [14]. In the second paper, we focused on patients’ assessment of the quality of nursing care [15]. The present article on quality of life is a complement to the previous works and the final article in the series of publications regarding Polish patients with multiple myeloma. All 3 articles have been based on analysis of the same patient population.

Therefore, in this questionnaire-based study of 246 patients with multiple myeloma, we aimed to determine the overall quality of life in the study group. We also examined differences by age and sex, and compared quality of life among patients treated with chemotherapy, autoHSCT, or supportive therapy. We used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in this study, which was conducted at 4 Polish centers from 2020 to 2021.

Material and Methods

ETHICS APPROVAL:

All participants received written information about the study’s purpose and methods. Informed consent was obtained from all patients involved in the study. All patients were assured of the anonymity of their responses. No data facilitating patient identification were collected. After completing the questionnaire, the patient placed it in a sealed envelope and returned it to the researcher. This study was performed in line with the principles of the Declaration of Helsinki and was supported by the Medical University of Warsaw. The university’s bioethics committee approved the study procedures (AKBE/271/2019).

STUDY POPULATION AND DATA COLLECTION:

The study was conducted from August 2020 to December 2021 in 4 centers across Poland (2 centers in Warsaw, 1 in Kielce, and 1 in Olsztyn). The first group of patients had multiple myeloma and were undergoing chemotherapy (between cycles 1 and 4 of treatment). During the induction phase of chemotherapy treatment, the patients typically received a treatment regimen that included a drug from the proteasome inhibitor group, such as bortezomib, an immunomodulatory drug, such as thalidomide, and a glucocorticoid. There was also the possibility of treatment in combination with other cytostatics [8]. In our study, we did not conduct a detailed analysis of the chemotherapy drugs taken by the patients. Therefore, it was not possible to perform an analysis distinguishing between the different types of medications used, which is one of the limitations of the study.

The second group consisted of patients after autoHSCT (between 2 and 7 days after), and the third group consisted of patients during supportive therapy following completion of treatment to maintain disease remission. The duration of the study in patients after autoHSCT was set at 2 to 7 days, to assess the symptoms associated with the transplant reported by the patients, before leaving the isolation room/ward. Each patient group in the study constituted a separate group, each undergoing just 1 phase of treatment. For instance, patients receiving induction chemotherapy who were included in the study were not subsequently subjected to the same study during autoHSCT.

The inclusion criteria were patients who had a confirmed diagnosis of multiple myeloma, spoke the Polish language, and agreed to participate in the study. Information on the method of treatment and confirmation of the diagnosis was obtained by analyzing the patients’ medical records. Questionnaires that were incomplete were not included. The exclusion criterion for the study was the lack of patient consent and failure to meet the inclusion criteria. Due to the COVID-19 pandemic and the rarity of multiple myeloma, contact with patients was limited. This made it difficult to collect data. Therefore, it was decided to use a mixed method of conducting the study (paper+electronic). The electronic questionnaire was sent by email to patients whose contact information was provided by the participating medical centers. In the paper version, 500 questionnaires were distributed and 207 responses were obtained, while in the electronic version, 39 questionnaires were sent and all were completed. The obtained data were entered into a Microsoft Excel spreadsheet, creating a database.

RESEARCH TOOL:

The study was conducted using a diagnostic questionnaire method with EORTC QLQ-C30, in paper and online versions [16]. The questionnaire includes 28 questions for which responses are given on a 4-point Likert scale and 2 questions with responses given on a 7-point scale. There are 15 scales included: global health status/quality of life (2 items related to the assessment of general health status and quality of life in the past week), physical functioning (5 items related to difficulties in performing activities such as lifting a shopping bag, walking, and the need for assistance with eating, dressing, bathing, or using the toilet), role functioning (2 items related to limitations in performing daily activities and engaging in hobbies), emotional functioning (4 items related to perceived tension, irritability, sadness, and worry), cognitive functioning (2 items related to difficulties in focusing while reading a book/watching television and difficulties with memory), social functioning (2 items related to disruptions in family life and obstacles in social life due to health status or treatment), fatigue (3 items related to feelings of fatigue, weakness, and the need for rest), nausea and vomiting (2 items related to feelings of nausea and occurrence of vomiting), pain (2 items related to the occurrence of pain and its impact on performing daily activities), dyspnea (1 item related to the occurrence of shortness of breath), insomnia (1 item related to the occurrence of sleep difficulties), appetite loss (1 item related to the feeling of loss of appetite), constipation (1 item related to the occurrence of constipation), diarrhea (1 item related to the occurrence of diarrhea), and financial difficulties (1 item related to financial challenges that occurred due to health condition or treatment).

The scales are divided into 3 domains: global health status, functional scales, and symptom scales. A higher score in the global health status domain reflects a better quality of life, a higher score on the functional scales signifies a high/healthy level of functioning, and a higher score on the symptom scales indicates a greater level of symptoms/challenges. The results for each scale range from 0 to 100 [16]. Access to the questionnaire was granted online following prior notification to the EORTC group.

STATISTICAL ANALYSIS:

Statistical analysis was performed by R language in the RStudio environment [17]. Data from the questionnaires were processed according to the appropriate guidelines, to obtain linearized coefficients. The normality of the data was assessed visually through histograms and Q-Q plots. Due to significant deviations from a normal distribution, data were presented as medians with interquartile ranges. To compare 3 groups, the Kruskal-Wallis test with post hoc multiple comparison tests was used. To compare 2 groups, the Mann-Whitney U test was used. The Spearman correlation coefficient was used for correlation analysis.

First, we analyzed the basic descriptive statistics of the study group. Then, the results for each scale of the EORTC QLQ-C30 were calculated without dividing the patients into treatment groups in order to illustrate the parameters of the entire study population. Subsequently, an analysis was conducted based on treatment groups, and correlation analysis was conducted between age and sex and the EORTC QLQ-C30 scales.

The sample size was calculated using the G*Power 3.1.9.7 program, with the following settings: alpha=0.05, effect size=0.25, power=0.80. The calculated sample size was 159, indicating that each group should consist of at least 53 participants. A simple random sampling method was used to select the sample. To assess the internal consistency of the questionnaire scales, the Cronbach alpha coefficient was computed. The statistical analysis was conducted in the RStudio program. P values less than 0.05 were considered statistically significant.

Results

BASELINE CHARACTERISTICS:

Responses were obtained from patients during chemotherapy (n=98), after autoHSCT (n=87), and during supportive therapy following completion of treatment to maintain disease remission (n=61). A total of 246 patients participated in the study. Detailed characteristics of the sample in total, as well as by treatment method, are presented in Tables 1–3.

Reliability analysis of the questionnaire according to the Cronbach alpha coefficient is presented in Table 4. Most scales had a good level of internal consistency. The exception was the social functioning scale (α=0.683).

GENERAL QUALITY OF LIFE AND POST HOC ANALYSIS:

The general characteristics of the questionnaire results are presented in Table 5. The highest scores were recorded for the scales of social functioning (M=65.718, SD=23.886) and emotional functioning (M=60.467, SD=22.353). The most bothersome symptom for patients was fatigue (M=59.937, SD=22.546).

In analyzing the study results, we tested the hypothesis that patients treated with autoHSCT for multiple myeloma would have a better quality of life than those treated with chemotherapy or supportive therapy. However, this hypothesis was not confirmed, as patients in the supportive therapy group demonstrated significantly better quality of life (P<0.001). The results of the comparisons between patients receiving different treatments are presented in Table 6. Significant differences were observed in all parameters studied.

The Kruskal-Wallis test with a post hoc multiple comparisons test was used to compare the results of each treatment group. The results of the analyses for the scales global health status, cognitive functioning, physical functioning, and financial difficulties are presented in the form of graphs (Figures 1–4). As can be observed in the chemotherapy treatment group, these coefficients reached the lowest values, indicating poorer quality of life (global health status scale) and worse cognitive and physical functioning than in the other groups. The highest values were achieved in the supportive therapy group. The greatest financial difficulties were observed in the chemotherapy group.

COMPARISON OF PATIENTS’ QUALITY OF LIFE BY SEX AND AGE:

As shown in Table 7, patients did not differ significantly in age according to sex (P=0.158). A significant difference was observed in the parameter of appetite loss (P=0.001), diarrhea (P=0.003), dyspnea (P=0.014), financial difficulties (P=0.033), and nausea and vomiting (P=0.002).

A correlation analysis was also conducted between age and individual parameters without differentiating patients by group (Table 8). A significant negative correlation was observed between age and the parameters global health status, physical functioning, cognitive functioning, diarrhea, and social functioning. Also, fatigue, nausea, pain, dyspnea, insomnia, constipation, and financial difficulties were significantly positively correlated with age.

We also conducted correlation analysis by age and group according to the type of treatment. In the chemotherapy group, there was a significant negative correlation between age and the parameters global health status (r_s=−0.420; P≤0.001), physical functioning (r_s=−0.460; P≤0.001), cognitive functioning (r_s=−0.320; P=0.001), and social functioning (r_s=−0.300; P=0.003). Also, fatigue (r_s=0.290; P=0.004), nausea and vomiting (r_s=0.300; P=0.003), pain (r_s=0.310; P=0.002), dyspnea (r_s=0.480; P≤0.001), insomnia (r_s=0.520; P≤0.001), and financial difficulties (r_s=0.440; P≤0.001) were significantly positively correlated with age. No significant correlations were observed in the autoHSCT group. On the other hand, in the supportive therapy group, a significant negative correlation was observed between age and the parameters of global health (r_s=−0.370; P=0.003), physical functioning (r_s=−0.330; P=0.010), role functioning (r_s=−0.330; P=0.010) and emotional functioning (r_s=−0.280; P=0.030). The correlation of age with insomnia (r_s=0.310; P=0.014) was positive.

Discussion

Recently, research on patient quality of life has become the object of interest in medical and health sciences. Hematological malignancies constitute a minority of all cancer diseases, and multiple myeloma is considered an uncommon condition. The goals of cancer therapy are to achieve disease remission, prolong survival, and improve the quality of life. Diagnosis, disease-related symptoms, adverse effects of treatment, and lack of social support undoubtedly negatively affect patient quality of life [10,12].

According to the results of our study, patients receiving supportive therapy had the highest level of quality of life and the lowest severity of symptoms. Patients in the chemotherapy group had the lowest level of quality of life and the highest severity of symptoms, which implies that this group of patients should receive intensified care. Older patients had a lower quality of life and worse disease-related symptoms.

In the detailed analysis, patients in the chemotherapy group showed the lowest levels of physical and emotional functioning. The most distressing symptoms in this group were insomnia and pain, likely related to their life situation, including receiving the diagnosis, adjusting to the disease, and undergoing aggressive first-line therapy. It is essential that patients receive care in a holistic and comprehensive way. Because of emotional challenges, many cancer patients benefit from psychological support or require intervention from a psychologist. The 2019 study conducted by Kang and Choi on 110 patients in Korea shows that uncertainty, anxiety, and depression are the main factors affecting the quality of life of multiple myeloma patients treated with chemotherapy [18].

Our results showed very few differences in the quality of life depending on sex. In this study, we observed slight differences in 5 parameters between men and women: appetite loss, diarrhea, dyspnea, nausea and vomiting, and financial difficulties. This is probably related to the patient’s unmet needs. The 2021 systematic review of Tsatsou et al indicates that patients with multiple myeloma most frequently reported unmet needs in the information, physical, emotional, and practical spheres, with female sex being one of the predictors of increased unmet needs for supportive care. Other important indicators include type of cancer, younger age, monthly income, and the coexistence of anxiety and depression [19].

Analysis of the above data indicated that as patient age increased, quality of life declined in the physical and social dimensions, and symptoms such as fatigue, nausea and vomiting, pain, shortness of breath, insomnia, loss of appetite, constipation, and diarrhea became more severe. This may be attributed to the presence of comorbidities and reduced physical and cognitive functioning. A study published in 2022, conducted on 100 patients diagnosed with cancer in Poland, indicates that the quality of life of patients treated with chemotherapy is worse and the level of symptoms is higher among older patients [20]. To enhance quality of life and prevent social exclusion, older adults should be encouraged to engage in social activities and remain socially connected. This should be done in a safe way because, as is widely known, chemotherapy causes many adverse effects, including decreased immunity; therefore, being in large groups of people is not recommended. Safe activities to do with other people include going for a walk, being in nature, or engaging in light physical exercise. It is known that these activities reduce cortisol levels while supporting the secretion of desired endorphins.

Financial difficulties also deserve attention, especially among older patients treated with chemotherapy. The 2023 study by Metin et al aimed to estimate the effect of caregiver financial situation on the quality of life of patients with multiple myeloma. The study involved 113 patients and their 113 caregivers in Turkey, with results showing that the quality of life of caregivers decreased as their financial situation deteriorated, which can affect the quality of life of patients with myeloma. Therefore, it is recommended that that nurses assess the financial situation of patients and their caregivers during care, and social workers and/or financial settlement specialists in hospitals should provide financial advice and help in solving financial problems [21].

Insurance for oncological treatment in Poland is financed from public funds. Patients qualified for treatment of a drug regimen are treated free of charge. When a patient has used available treatment options, and there is a need to use a specific, expensive drug to save a life or health, it is possible to reimburse the drug as part of emergency access to drug technologies. Patients can also access commercial medicines [22,23]. The expenses associated with treatment can limit the patient’s individual budget. Post-discharge recommendations are often financially problematic, such as organizing care at home and purchasing medicines or foodstuffs for special medical purposes. Malnutrition, especially in older people with cancer, is associated with longer hospital stays, higher medical costs, and hospital readmissions [24].

Research on quality of life is often an area of interest in modern evidence-based nursing practice. A patient with any diagnosed disease requires holistic care and having their needs met, regardless of whether it is a common or rare disease. The literature includes many articles on the general quality of life and care in commonly occurring cancers, such as colon cancer, lung cancer, and prostate cancer in men, and breast cancer, endometrial cancer, and ovarian cancer in women [25]. Therefore, hematological nursing must evolve to meet these challenges. The present study can contribute to a better understanding of the challenges faced by patients with hematological diseases. This insight can help nurses plan care that aligns with patients’ needs and expectations, ultimately improving their quality of life.

The papers and results presented here indicate that attention must be paid to the problems and needs of elderly patients and/or patients treated with chemotherapy whose quality of life needs improvement. This group of patients requires intensified actions and nursing care, as well as psychological support.

This study had limitations. The first is the small sample and unequal groups. Because of issues with patient safety, it was difficult to obtain consent from other hospitals to conduct the study, especially during the COVID-19 pandemic. Patients frequently declined to participate in the study because of poor health, which could have distorted the results obtained in individual groups of patients. The cross-sectional nature of the study limited the ability to conduct causal analyses. Another significant limitation of the study was the absence of comparisons between patients treated with different chemotherapy drugs or based on disease symptoms and physical condition. A detailed analysis of the medications used during supportive therapy was also not performed. Additionally, a physical examination of the patients was not conducted. Quality of life can be influenced by the severity and phase of the disease, among other factors. In our study, we did not analyze these aspects, which is also a significant limitation. In future studies, it would be valuable to examine the effect of type of chemotherapy drugs used and disease phase on quality of life.

Conclusions

The quality of life in patients with multiple myeloma is related to type of treatment and patient age. Patients in the supportive therapy group reported the highest quality of life. Patients in the chemotherapy group reported the lowest quality of life. Quality of life also declined with age. Difficulties in physical and cognitive functioning in daily life and social settings highlight the need to increase care efforts for these patient groups.